Calcium and Vitamin D are Safe for Heart Health

Huge study of ½ million adults age 40-69: calcium & D supplements pose no cardiovascular risk (heart attack, etc.) in the UK Biobank study:

fb.me/IOHg07RL

Vitamin D Testing & 3rd Party Certification

A letter in a recent medical journal stated that in a recent study the only vitamin D supplement to pass the authors’ potency testing was a USP-verified product.  The authors explicitly endorsed the USP certification program and the brands that utilize this standard. [1] News reports are duly reporting that consumers should only purchase USP-verified Vitamin D. (12) But the data in the study did not justify that conclusion, so those news reports were based on inaccurate information and are therefore wrong.  

The  authors claimed that “the Food and Drug Administration [FDA] does not regulate vitamin D supplements.”  ¹  This is simply not true.  [2]  The FDA does indeed regulate all dietary supplements, including Vitamin D. ²  A summary of dietary supplement regulation is posted on that agency’s website. [3]^{, 9}   There are also various third-party summaries of current dietary supplement regulation available. [4]^{, [5], [6], [7], [8], 10} 

The USP-verified OTC standards require a potency of 90% - 110% of the active label claim, as the authors point out.  But this allows levels which are below the minimum required by the Dietary Supplement Health and Education Act of 1994 and the resulting FDA current Good Manufacturing Practices (cGMPs) that regulate supplement manufacturing and labels.  The federal cGMPs require greater or equal to 100% potency; the capsules must at least match the label claims.  This means that a product tested at 99% potency would be acceptable by the USP standards, but would not meet the FDA cGMP standards set in the regulations governing dietary supplements.  This also means that a USP-Verified product could actually be deemed “misbranded” under these regulatory standards, and therefore illegal. So you can quickly see that the USP’s OTC (over the counter) drug standard is not applicable to dietary supplements. ¹⁰  

In the letter published in that medical journal the authors reported that four of the 12 brands tested had samples that met the authors’ standards as being within their stated acceptable range of variance from label claim, yet only one of these was from a USP-verified company. Why was that brand singled out as superior when at least 3 other brands were within those same chosen (and as we discussed already, unacceptable) limits? And why did the authors specifically endorse that brand‘s certification program when admittedly one of the two USP-verified brand’s products tested actually failed this testing? ¹  That’s a 50% failure rate, and the one USP-verified product that didn’t fail that standard still did not reliably meet the cGMP legal standard.  To me, an experienced science writer, these inconsistencies of logic suggest a bias against the non-USP-verified brands and an unjustified conclusion that conveniently met the authors’ preconceived notions of dietary supplements being ‘unregulated’.  

In this study, only 5 brands are USP-verified (Berkley & Jensen, Kirkland, Nature Made, Sunmark, TruNature).  All are sold in mass market (Albertsons, BJ’s Wholesale Club, Costco, CVS, Eckerd, Giant, Health Mart, Hy-Vee, K-Mart, Kroger, Long’s, Osco Drug, Ralph’s, Rite-Aid, Safeway, Sam’s Club, Stater Bros, Super Valu, Target, Valu-Rite, Walgreen’s), not health food stores. [9] Brands sold in the natural products channel (health food stores) typically don’t verify their products to the non-compliant USP standards. Most good natural products brands are certified by different 3^rd party organizations that certify their compliance to the FDA’s cGMP standards, which are the law of this land.  [10]^, [11] We don’t know if any of the brands tested were third-party certified by these other organizations because the authors did not disclose those brands or discuss any other claims of third-party certification. ¹  

Why do people buy vitamins at health food stores instead of drug stores in the first place?  Many people reject some of the pharmaceutical ingredients that are commonly used in products sold in that channel but which are not used in vitamin products sold in the natural channel.  These questionable ingredients include petroleum and coal tar derivatives, talc, hydrogenated oil, artificial colors/flavors/sweeteners, crospovidone, butylated hydroxytoluene, and hypromellose.

The moral of this story is “don’t accept everything you read,” even if published by well-credentialed scientists in a “prestigious” scientific journal and dutifully reported by well-meaning news organizations.  Under U.S. law, USP-Verified is not an acceptable standard for dietary supplements because its standard fails to meet the legal requirements for dietary supplements.  Instead, look for dietary supplements that are third-party GMP-certified in order to assure that your vitamins are manufactured under proper conditions to assure safety and efficacy, and are properly tested to meet 100% of label potency as required by law.  

REFERENCES (links accessed Feb. 18, 2013)

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[1] http://archinte.jamanetwork.com/article.aspx?articleid=1570096

[2] http://www.fda.gov/Food/DietarySupplements/default.htm

[3] http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm071547.htm

[4] http://honestnutrition.blogspot.com/2013/02/how-dietary-supplements-are-regulated.html

[5] http://www.npainfo.org/NPA/Communications/SeparatingSupplementFactsfromFiction.aspx

[6] http://www.crnusa.org/leg_DSHEApub.html

[7] http://www.crnusa.org/leg_glance.html

[8] http://americannutritionassociation.org/newsletter/assessing-claims-functional-foods-nutritional-supplements

[9] http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements

[10] http://www.npainfo.org/NPA/EducationandCertification/GMPCertification/NPA/EducationCertification/NPAGMPCertificationProgram.aspx?hkey=d37fc8c5-7b43-4a6d-bcf4-af67d5814bfe

[11] http://www.npainfo.org/NPA/EducationCertification/GMPCertifiedCompanies.aspx

12 http://www.koinlocal6.com/news/local/story/Taking-Vitamin-D-Dont-trust-that-bottle/94U3oiVyCU2bv85MQxYDtw.cspx

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Flu Shot Realities

Nutrition and Seasonal Flu

Antibiotics fight bacteria but won’t help against viral infections, and there are limited medical options. Flu drugs must be taken within 48 hours of the first symptoms of influenza and only claim to reduce symptoms by about 1.5 days. [1], [2]

Flu shots are only effective against 1-3 strains of influenza; depending on how lucky the researchers’ guess was several months earlier. But exposure to one or more flu strains, such as by getting a flu shot, actually make us more susceptible to infection from other virus strains by reducing our immune response.  Researchers know that, theoretically, when people are exposed to bacteria or a virus, it can stimulate the immune system to create antibodies that facilitate the entry of another strain of the virus or disease. For example, Canadian researchers in four separate studies found that people who had received the seasonal flu vaccine in the past were more likely to get sick with the H1N1 virus. [3]

There is evidence that the nutrient status of the host even affects the genetic expression of viruses. An unsuitable environment like a well-nourished body inhibits the ability of a virus to freely replicate and thrive. This not only makes viruses more virulent, but also more prone to mutate inside us to become more immune- and drug-resistant strains if we are nutrient deficient! ^{[4], [5], [6], [7]}

Research going back over a century has proven that nutrient deficiencies, for example of vitamins A or D, can lead to increased susceptibility to infectious diseases. A well-known and decades-old example is the strong association of vitamin A deficiency with the development of more severe measles infections, leading to a much higher rate of mortality. ⁵

Although the immune response has been demonstrated to be impaired in nutritionally deficient hosts, the actions and vigor of the virus itself may also be affected by the nutritional deficiency. Viruses have been shown to develop increased virulence due to changes in their genomes when replicating in a nutritionally deficient host. The exact mechanism for viral genetic changes is not well documented but seems related to increased oxidative stress in the host. For example, selenium-deficient mice were more susceptible to viral infections, and developed severe forms of illnesses even when infected with mild viral strains. Both the immune system and the viral systems were affected by the nutrient deficiency in ways that strengthened the virus and weakened the host. ⁵

Volunteers inoculated with live attenuated influenza virus are more likely to develop fever and evidence of an immune response in the winter when vitamin D levels are naturally low.  And an interventional study showed that vitamin D reduced the incidence of respiratory infections in children. [8]

Compelling epidemiological evidence indicates that vitamin D deficiency is a stimulus causing seasonal flu rates to be much higher in the winter months than the summer months. Evidence now confirms that lower respiratory tract infections are more frequent, sometimes dramatically so, in those with low serum vitamin D levels. In an intervention study, 800 IU of vitamin D daily reduced seasonal flu levels in winter months to the low levels commonly reported in summer months...virtually eliminating seasonal flu in that population. [9]

We can see that vaccines and flu drugs convey only limited protection and treatment against viral infections, and that the wisest course is to fortify our immunity with adequate nutrient intake.

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[1] http://www.tamiflu.com/treat.aspx 

[2] http://www.relenza.com/

[3] CBC News 9/23/09; Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion

[4] Cunningham-Rundles S, McNeeley DF, Moon A.  Mechanisms of nutrient modulation of the immune response.  J Allergy Clin Immunol. 2005 Jun;115(6):1119-28; quiz 1129. Review.

[5] Zaslaver M, Offer S, Kerem Z, Stark AH, Weller JI, Eliraz A, Madar Z. Natural compounds derived from foods modulate nitric oxide production and oxidative status in epithelial lung cells.  J Agric Food Chem. 2005 Dec 28;53(26):9934-9.

[6] Calder PC, Kew S.  The immune system: a target for functional foods? Br J Nutr. 2002 Nov;88 Suppl 2:S165-77.

Janeway, Charles A.; Travers, Paul; Walport, Mark; Shlomchik, Mark (2001) Immunobiology, 5th Ed., Garland Publishing, New York and London.

[7] Beck MA, Handy J, Levander OA. Host nutritional status: the neglected virulence factor. Trends Microbiol. 2004 Sep;12(9):417-23. Review. PMID: 15337163

[8] Cannell JJ, Vieth R, Umhau JC, Holick MF, Grant WB, Madronich S, Garland CF, Giovannucci E. Epidemic influenza and vitamin D. Epidemiol Infect. 2006 Dec;134(6):1129-40. Epub 2006 Sep 7. Review. PMID: 16959053

[9] Cannell JJ, Zasloff M, Garland CF, Scragg R, Giovannucci E. On the epidemiology of influenza. Virol J. 2008 Feb 25;5:29. Review. PMID: 18298852

Natural Controversies: Free Webinar May 15th at 7 PM (CT)

I'm giving a free public webinar May 15th 7 pm CT on Natural Controversies. Register here:  http://americannutritionassociation.org/civicrm/event/info?reset=1&id=32 and use this code for free registration as my guest: SPKGST5629

We’ve all seen contradictory information about natural health products. Sensational reports may depict certain ones as always good or bad for us, but these are often based on inaccurate information. A combination of ignorance, bias, and other errors contribute to this mass confusion.

Take a look at the scientific data that reveals the truth behind some Natural Controversies:

• What are some of the dieting secrets that work long term?
• Some experts claim that all sugars are the same to the body; others claim that certain sweeteners like fructose are bad for you. What’s good and bad about fructose and how does it work in the body?
• Aren’t the vitamins and minerals in food better for us than the forms commonly used in dietary supplements?
• A few years ago, doctors routinely warned us against taking high doses of vitamin D but now it’s the latest thing.
• How much vitamin D is considered healthy?
• What are the safety limits?
• What is the difference between its forms, D-2 and D-3?
• Some fish oils are in a triglyceride form while others are in a form called ethyl esters. What are the differences and benefits of each form?
• Soy foods are highly controversial; with some health gurus warning against its use and others promoting it as an important health food. What does science tell us about the safety of soy foods versus their potential benefits?

• Vitamin E had been touted as important to cardiovascular health until recent studies questioned its safety. Is it safe, at what levels, and why is there so much controversy over this basic essential nutrient?

• Are stearates hydrogenated? Bad for us?

Functional Doses of Vitamins and Minerals for Bones

• Protein: 0.8 grams per kilogram of body weight

• Calcium: Over 1 gram per day

• Magnesium: 310 – 420 mg per day

• Zinc: 15 mg per day

• Copper: 2.5 to 3 mg per day

• Boron: 3 mg per day

• Manganese: 5 mg per day

• Potassium: 3,500 to 4,000 mg per day

• Vitamin D: over 500 IU daily

• Vitamin K: Levels are not well understood; at least 90 mcg/d for women and 120 mcg/d for men

• Vitamin C: over 500 mg daily

• Vitamin A: 2333 IU in women and 3000 IU in men; avoid low and excessive amounts

Palacios C. The role of nutrients in bone health, from A to Z. Crit Rev Food Sci Nutr. 2006;46(8):621-8. Review. PubMed PMID: 17092827.

A study found that about 1/4 of all otherwise normal infants have evidence of infantile rickets while still in the womb. It is likely that tens of thousands of infants are being sent home from the hospital with multiple fractures because no one has ever done a study looking for asymptomatic fractures.

Mahon P, et al. Low maternal vitamin D status and fetal bone development: cohort study. J Bone Miner Res. 2010 Jan;25(1):14-9.

Nutrients for Bone and Joint Health Interview

This interview was given to Whole Foods Magazine, excerpts were published in the February 2011 issue:

Despite evidence in recent medical journals, including several review studies calling for a far higher RDA and UL (upper limit) that would be five times the previous levels, the IOM held true to its conservative bent and raised the RDA and the UL; but only by 50% by only 100%, respectively . Observers are somewhat disappointed, but not really surprised. The most controversial part of the IOM committee’s report is that the only proven role for vitamin D is in bone and calcium metabolism, combined with its finding that most Americans already get enough for those benefits. That should come as news to researchers from Mayo Clinic operating under an NIH grant who recently reported that “Vitamin D insufficiency is common globally and in the United States. Approximately 25-50% of patients seen in routine clinical practice have vitamin D levels below the optimal range…” It also should be news to European regulators that recognize vitamin D’s beneficial effects on muscles, immunity, inflammation, cellular health, and reproduction. We recognize the new increased recommendations for vitamin D and the new higher safety recommendation, but believe that these numbers are insufficient to support vitamin D’s roles that go beyond calcium and bone health.

The need for joint and bone health nutrients in general increases with age. Aging also tends to reduce absorption of nutrients, forcing us to take higher amounts and better forms in order to assure adequate nutrition. The tendency of many seniors to cut back on meals, for reasons such as loss of taste or smell or interest in cooking, may also increase the need for supplementation of essential nutrients. The major joint and bone problems increase with age, and studies have shown the ability of relevant nutrients to maintain healthy bone and joint structures during these vulnerable times of life. Older customers that are more likely to take calcium supplements also tend to have diminished stomach acid available for digesting calcium from food and non-chelated (predigested) forms, so tend to do better with the predigested forms. These include calcium as citrate, malate, ascorbate, or bonded to specific amino acids; all are weak acidic sources that form a stable bond with the alkaline calcium and the resulting compound simulates the calcium complexes formed naturally during proper digestion.

While calcium and vitamin D are known for their role in bone and calcium metabolism, there are other nutrients necessary for bone health. These include silica, boron, magnesium, vitamins C and K, etc. protein. Comprehensive bone formulas include over a dozen nutrients, which are also available singly.

Children need to get sunshine, exercise, and a variety of calcium from food sources to ensure the body’s needs for bone health. If the child does not eat ample amounts milk and dark green leafy vegetables, they may need to complement the diet with appropriate dietary supplements.

Adults need to take care of their bodies and not impact the joints too much with hard exercises or excess weight. Support the joints nutritionally with glucosamine, vitamin C, a good multivitamin, and natural substances that modulate inflammation.

One should not neglect the long-term benefits of glucosamine to maintain joint distances that may otherwise erode, for example, while seeking fast-term temporary relief of aches and pains. By providing those products in both categories as well as overlapping combination products, we can supply a more holistic and sustainable nutritional joint support program.

Many of the Joint Structural Support Products contain varying amounts of glucosamine and/or chondroitin, as well as MSM, Hyaluronic Acid, and other well-known ingredients.

Increased US Vitamin D Recommendations

Chicago Tribune’s report “Don’t overdo vitamin D, calcium, experts warn” focused only on the risks of taking very high doses of these essential nutrients but missed the most important part of the new NIH Institute of Medicine (IOM) report by omitting that there are now higher daily recommended allowances (RDA) for vitamin D intake. It’s uncommon to take toxic amounts of vitamin D but far more common for some to be deficient, with resultant health deficits and increased healthcare costs.

Trib readers didn’t learn that the IOM panel raised vitamin D’s RDA by 50% to 600 IU (800 IU if over age 70), while doubling the tolerable Upper Limit (UL) to 4,000 IU.

In Chicago, it’s already been months since we could make any of the “sunshine vitamin” from sunlight, since the sun must be high enough in the sky so one’s shadow is shorter than his/her height. Darker skin allows less vitamin D production even with adequate sunlight; sunscreen blocks it. Chicagoland residents must rely on fortified foods and dietary supplements as primary sources of vitamin D for over half the year.

The IOM statement that people get enough vitamin D refers only to its conclusion that bone health is the only as yet proven role for this nutrient. Yet the IOM’s European counterpart, the European Food Safety Agency, recognizes an established cause and effect relationship between vitamin D and normal muscle health, immunity, inflammation, reproduction, and cellular health. Researchers have estimated that these additional benefits occur when people take 1,000-2,000 IU daily. Scientific toxicity reviews show safety up to intakes of 10,000 - 20,000 IU daily; multiples of the recently doubled UL.

By ignoring vitamin D’s increased RDAs and other benefits, and publishing broad statements that focus primarily on the unlikely “risks” of vitamin D and calcium supplementation, Tribune readers missed important parts of the IOM report.

New evidence that many Americans don't get sufficient vitamin D!

These quotes are from an NIH-funded study at Mayo Clinic, just published by the the American Society of Hematology in its medical journal "Blood" (Shanafelt TD, et al. Vitamin D insufficiency and prognosis in chronic lymphocytic leukemia (CLL). Blood. 2010 Nov 3. PMID: 21048153). It suggests that 30-40% of the general population is deficient in vitamin D, and that this vitamin has a "central role" in the body beyond bone health:

"Vitamin D insufficiency is common globally and in the United States. Approximately 25-50% of patients seen in routine clinical practice have vitamin D levels below the optimal range, and it is estimated that up to 1 billion people worldwide have vitamin D insufficiency." 1-3

"Vitamin D has a central role in maintaining serum calcium and skeletal homeostasis as well as multiple other cellular effects including regulation of differentiation, proliferation, apoptosis, metastatic potential, and angiogenesis.5 Several reports now suggest low serum 25(OH)D levels may be associated with increased incidence of colorectal,6,7 breast,8,9 and other cancers.10 Consistent with these results, one population based, double-blind, randomized placebo-controlled trial found women who increased their daily vitamin D intake by 1100 IU reduced their risk of cancer by 60-77%." 11

"Consistent with the prevalence of hypovitaminosis D in the general population,1-3 30-40% of CLL patients in the two observational cohorts studied had vitamin D insufficiency."

These quotes cited the following references in the statements posted above:

1.Thomas MK, Lloyd-Jones DM, Thadhani RI, et al. Hypovitaminosis D in medical inpatients. N Engl J Med. 1998;338(12):777-783.
2. Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006;81(3):353-373.
3. Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357(3):266-281.
5. Bikle D. Nonclassic actions of vitamin D. J Clin Endocrinol Metab. 2009;94(1):26-34.

6. Gorham ED, Garland CF, Garland FC, et al. Vitamin D and prevention of colorectal cancer. J Steroid Biochem Mol Biol. 2005;97(1-2):179-194.
7. Yin L, Grandi N, Raum E, Haug U, Arndt V, Brenner H. Meta-analysis: longitudinal studies of serum vitamin D and colorectal cancer risk. Aliment Pharmacol Ther. 2009;30(2):113-125.
8. Crew KD, Shane E, Cremers S, McMahon DJ, Irani D, Hershman DL. High prevalence of vitamin D deficiency despite supplementation in premenopausal women with breast cancer undergoing adjuvant chemotherapy. J Clin Oncol. 2009;27(13):2151-2156.
9. Chen P, Hu P, Xie D, Qin Y, Wang F, Wang H. Meta-analysis of vitamin D, calcium and the prevention of breast cancer. Breast Cancer Res Treat. 2009.
10. Garland CF, Gorham ED, Mohr SB, Garland FC. Vitamin D for cancer prevention: global
perspective. Ann Epidemiol. 2009;19(7):468-483.
11. Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium
supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007;85(6):1586-
1591. 

European regulators recognize effects of vitamin D beyond bone health

To date EFSA (the European Food Safety Agency), has published positive opinions on article 13.1 health claims relating to beneficial effects of vitamin D supplements not only on bones and teeth, but also relating to muscles, immunity, inflammation, and reproduction. * Yet the United States' Institute of Medcicine (IOM) committee did not reach similar conclusions and therefore did not consider the need for amounts higher than needed just for bone health when recently resetting the recommended and upper limits for vitamin D. (* from nutraingredients.com). For more on the FDA decision, see:
http://honestnutrition.blogspot.com/2010/11/us-increases-recommendations-for.html

Here's what the EFSA has published about these positive benefits (I bolded some text to highlight these points):


"The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin D and contribution to the normal function of the immune system and healthy inflammatory response, and maintenance of normal muscle function."
http://www.efsa.europa.eu/en/scdocs/scdoc/1468.htm

"The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin D and maintenance of normal bone and teeth, absorption and utilisation of calcium and phosphorus and normal blood calcium concentrations, and normal cell division."
http://www.efsa.europa.eu/en/scdocs/scdoc/1227.htm

U.S. Increases Recommendations for Vitamin D Intake but Misses the Mark

U.S. Increases Recommendations for Vitamin D Intake but Misses the Mark

As you probably know from news reports, the recommendations for individual consumption of vitamin D has now increased, as has the tolerable Upper Limit (UL) that indicates a higher intake level at which the vast majority of people will not suffer any unpleasant side effects. But these recommendations are controversial for being too conservative, and at the same time the report has been sensationalized in the popular media with an inappropriate emphasis on possible side effects of megadoses.

The Institute of Medicine (IOM), the health arm of the National Academy of Sciences, is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public. Through more than three dozen sets of guidelines, known as Dietary Reference Intakes (DRIs), IOM provides estimates of the amounts of nutrients that individuals need to consume each day. Health care professionals and policy makers, including federal nutrition officials who develop nutrition programs as well as the food industry, rely on this guidance from the IOM. The reference numbers that you see on food and dietary supplement labels, such as Daily Values (DV), DRIs, and Recommended Daily Allowances (RDAs), are generated by IOM. (1) These values are also utilized by some foreign governments as authoritative references on which to base their own food and supplement regulations.

The good news is that, in a report issued by IOM on November 30, 2010, the RDA has now increased by 50% (from 400 IU to 600 IU) and the tolerable Upper Limit has now doubled (from 2,000 IU to 4,000 IU). Also, the RDA for adults over 71 years old has increased to 800 IU daily. (2) This means that the new recommendations are often higher than the 400 IU that is found in a typical multivitamin or calcium+D formula, thus requiring additional supplementation to meet the RDA. And the leeway for safe use at the upper end is now double what it was before, making such supplementation at higher levels still within a margin generally accepted as safe; at least up to 4,000 IU, though as usual that number is deliberately set low and has a large safety margin.

IOM’s report stating that most Americans have adequate circulating levels of vitamin D is somewhat controversial, as it utilizes a standard of 20 ng/mL (equivalent to a measure of 50 nmol/L) (3) that is not universally accepted as adequate for optimal health by many modern vitamin D researchers. While that amount may adequately support bone health, which was (as usual) the primary focus of the IOM committee, there are vitamin D receptors on many other human cells and this vitamin reportedly plays an important role in cardiovascular disease (4), immune health (5), prostate and breast health (7), blood sugar metabolism (6), cancer prevention (7,8) , and a host of natural processes. One recent report stated that, “The desirable serum 25 (OH) D levels is at least 100 nmol/L, a level that has generally been found to provide most of the health benefits of vitamin D.” (9) This recommendation is twice as high as the new RDA, evidencing the controversial nature of IOM’s RDA process.

However, the IOM committee admittedly based its recommendations solely on vitamin D’s effects on bone health after reviewing numerous studies on other benefits and concluding that more study is required to generate the level of evidence that IOM requires to set its recommendations. Committee chair Catharine Ross was quoted as saying, “Amounts higher than those specified in this report are not necessary to maintain bone health.” (10) As the amount of science in these other areas grows, so should the levels recommended for general health. But statements such as that by Dr. Ross that “people don't need more than the amounts established in this report” refer only to bone health and should not be construed as denying the fact that other benefits at higher levels of intake have been reported, though not as consistently as the IOM committee would need to accept them as conclusive enough to revise its recommended levels upward.

Based on current research, natural health advocates typically recommend levels 50-100% higher than the IOM report recommends in order for people to obtain the full protective benefits of vitamin D, and many physicians who test for this vitamin ask their patients to meet or exceed that higher level. This is perhaps the most controversial part of the report, and I predict that a barrage of higher numbers appearing in medical reports as protective will force another overdue round of RDA changes in perhaps another 10-15 years. In my opinion, the IOM is always behind the times in the area of nutrient recommendations, being by nature super cautious. We dared to hope, but nobody really expected the IOM panel to accept the evidence of recent published review studies in medical journals and raise both the RDA and UL to the recommended five times their previous levels, and frankly we were not surprised that they didn't. These special panels are typically very conservative and hesitant to make dramatic changes, and are comprised with well-qualified general nutrition experts but not with experts in the particular area in question who might push for acceptance of higher levels.

People have already been taking over 2,000 IU daily, the old tolerable Upper Limit, without apparent harm and will probably continue to take over the new 4,000 IU UL as well. Clinical science indicates that higher levels are still quite safe, at least up to 10,000 IU daily for most adults. In 2007 a review published in the American Journal of Clinical Nutrition applied the same risk assessment methodology used by the Food and Nutrition Board (FNB) to derive a proposed revision of the safe Tolerable Upper Intake Level (UL) for vitamin D. (11) Noting an absence of toxicity in trials conducted in healthy adults that used a vitamin D dose ≥250 µg/d (up to 10,000 IU of vitamin D3), a new UL of 10,000 IU was confidently proposed, but was apparently not accepted by the IOM. Nor was the recommendation for a new RDA to be raised to 2,000 IU.

In fact, the 10,000 IU daily UL proposal may have been conservatively low; so what does that make the revised tolerable UL of only 4,000 IU? According to a report in the journal Nutrition Reviews, "The input needed for efficacy, in addition to typical food and cutaneous [sunlight] inputs, will usually be 1000-2000 IU/day of supplemental cholecalciferol [vitamin D3]. Toxicity is associated only with excessive supplemental intake (usually well above 20,000 IU/day)." (12) [Italicized words added for clarity]

Dietary supplement manufacturers already were not allowed to make disease claims on dietary supplements without (always reluctant) FDA approval, so the IOM’s report that vitamin D has not been proven to prevent various diseases is not news for them. However, consumers will continue to be exposed to positive reports on the vitamin and most will understand that just because it has not yet been "proven" to prevent certain diseases doesn't mean that it doesn't, especially at levels higher than needed purely for bone health, nor does it suggest that there is no supporting evidence that it still may be an important preventative factor.

The government standard of proof in the dietary supplement area has been frequently criticized and the FDA in fact has lost several federal court cases, where courts have ordered the agency to comply with the law allowing such claims where substantial evidence already exists for some supplements’ role in disease prevention (for example, selenium and cancer). (13,14) Of course, almost never is anything "proven" in a scientific field; theories rule most scientific endeavors. But that should not suffice to allow the government to muzzle legitimate science nor to prevent the public from taking natural nutrients at levels that they may require due to their own individual biochemistry and relevant environmental factors. In this case, the new RDA and UL are simply baby steps in the right direction, but perhaps the full knowledge of vitamin D’s health benefits is still in its infancy.

REFERENCES:

1. http://www.iom.edu/About-IOM.aspx Accessed November 30, 2010
2. Dietary Reference Intakes for Calcium and Vitamin D. Food and Nutrition Board, Institute of Medicine, National Academies. Released: November 30, 2010
3. http://ods.od.nih.gov/factsheets/VitaminD-Consumer/ Accessed November 30, 2010
4. Wallis DE, Penckofer S, Sizemore GW. The "sunshine deficit" and cardiovascular disease. Circulation. 2008 Sep 30;118(14):1476-85. Review. Erratum in: Circulation. 2009 Jun 2;119(21):e550. PubMed PMID: 18824654.
5. Cannell JJ, Zasloff M, Garland CF, Scragg R, Giovannucci E. On the epidemiology of influenza. Virol J. 2008 Feb 25;5:29. Review. PubMed PMID: 18298852; PubMed Central PMCID: PMC2279112.
6. de Boer IH. Vitamin D and glucose metabolism in chronic kidney disease. Curr Opin Nephrol Hypertens. 2008 Nov;17(6):566-72. Review. PubMed PMID: 18941348; PubMed Central PMCID: PMC2882033.
7. Skinner HG, Michaud DS, Giovannucci E, Willett WC, Colditz GA, Fuchs CS. Vitamin D intake and the risk for pancreatic cancer in two cohort studies. Cancer Epidemiol Biomarkers Prev. 2006 Sep;15(9):1688-95. PubMed PMID: 16985031.
8. Garland CF, Garland FC, Gorham ED, Lipkin M, Newmark H, Mohr SB, Holick MF. The role of vitamin D in cancer prevention. Am J Public Health. 2006 Feb;96(2):252-61. Epub 2005 Dec 27. Review. PubMed PMID: 16380576; PubMed Central PMCID: PMC1470481.
9. Grant WB, Schwalfenberg GK, Genuis SJ, Whiting SJ. An estimate of the economic burden and premature deaths due to vitamin D deficiency in Canada. Mol Nutr Food Res. 2010 Aug;54(8):1172-81. PubMed PMID: 20352622.
10. http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13050 Accessed November 30, 2010
11. Hathcock JN, Shao A, Vieth R, Heaney R. Risk assessment for vitamin D. Am J Clin Nutr. 2007 Jan;85(1):6-18. Review. PubMed PMID: 17209171.
12. Heaney RP. Vitamin D: criteria for safety and efficacy. Nutr Rev. 2008. Oct;66(10 Suppl 2):S178-81. Review. PubMed PMID: 18844846.
13. http://www.emord.com/FDA_Agrees_to_Allow_Selenium_Qualified_Health_Claims.html Accessed November 30, 2010
14. http://www.kelleydrye.com/publications/client_advisories/0576 Accessed November 30, 2010

Calcium & Cardiovascular Health: My review of the latest meta-analysis

At the end of July (2010) there was another nasty swipe at dietary supplements (Natural Health Products, for our Canadian friends). Again, the negative report came not from a single study, but from a particularly troubling type of report called a meta-analysis. Rising like a spider on a lethal web, this type of report keeps popping out of nowhere, attempting to make connections between studies where none may have been found before. In fact, we rarely see a competently designed meta-analysis on nutrients because there are many variables that come into play that simply don’t exist for isolated pharmaceutical drugs that aren’t (or at least aren’t supposed to be) present in our normal food supply. The interplay of nutrients affects each others’ metabolism, serum levels, and activities in a live human body. So when I see yet another meta-analysis getting major press coverage based on fairly flimsy evidence, I cringe and wonder why researchers and journalists fail to see the obvious flaws in their big story. Perhaps drug researchers are trying to branch out into nutrient research and just get in over their heads because they fail to see the complexity of nutrient research design.

The alleged danger this time: supplemental calcium was associated with a 30% increased risk of myocardial infarction, so the risks now outweigh the benefits. But was this proven? NO! Absolutely not. Nada. Zilch. Even the authors of this analysis know better than to claim that their report was definitive proof of these alleged dangers.

First of all, there was no increase in deaths in the groups given supplemental calcium. There was an increase in non-fatal heart attacks; but only in people who had already high calcium intake from their diets and also took high doses of supplemental calcium that they apparently didn’t need. And there was no problem demonstrated when calcium was given along with supplemental vitamin D, so maybe the problem was really that some folks had inadequate levels of that essential vitamin to deal with a high calcium intake.

But since vitamin D is both in the diet (as is calcium) and made from sunshine under the right conditions, these meta-analysis authors don’t really know how much vitamin D these people actually had, confounding their data. They don’t know because it would have required a rigorous study design that looked at all three intakes: food, supplements, and sunlight exposure at the times of day and year where vitamin D could be internally produced. Or at least measuring the serum before treatment to detect vitamin D levels and eliminate that as a variable. But that wasn’t done, perhaps because these researchers only looked at other people’s studies rather than running a human clinical trial themselves.

This points out perhaps the major problem with this type of study: since a meta-analysis is only a statistical model that cannibalizes previously published work to “mine” data in ways that were not planned by the original study designers, it has many built-in limitations. For example, cardiovascular outcomes were admittedly not intended as the primary endpoints in any of the 15 studies ‘Mixmastered’ together to make up this meta-analysis, so data on cardiovascular events were not gathered in the usual standardized manner. In plain English: the few cherry-picked studies included in this report had not done the type of standardization and control of variables needed to properly design a robust cardiovascular study because the original studies actually were looking at calcium’s effects on bone health, not heart health. This was, in fact, an admitted limitation of the current meta-analysis.

A good meta-analysis tries to pick the largest possible number of studies with similar designs to pool their results and in effect try to get a larger, hopefully more significant number of virtual test subjects. The farther from that model the meta-analysis gets, the more variables get introduced to confound the researchers. And since control of variables is the essential competence of the scientific method, we unfortunately find that an inexpertly executed meta-analysis is a misleading and erroneous scientific tool; like a ruler that has not been calibrated correctly and implies that our measurements are accurate when they may be way off the mark.

Researchers utilizing the imprecise tool of meta-analysis should not delude themselves that their work is definitive, because it almost never is. Nor should they become media darlings because they have espoused new theories - based on an unproven brew of mathematical models - that usually are already contradicted by a lot of better designed primary science. Nor should their attempts to re-examine previously published studies for results which were never intended to be measured scare us away from taking essential nutrients, which are commonly more healthful than harmful. As the current meta-analysis reported, the problem was that people who ate a lot of calcium who also took a lot of supplemental calcium without the benefits of taking vitamin D or other bone-forming cofactors had more non-fatal heart attacks. No one died. This implies that, at the most, one should not take a single nutrient in excess as if it were a magic drug, especially when they probably already get plenty in the diet. Don’t most of us know that already?

Nutrients are synergistic; therefore an imbalanced diet, including unneeded supplements that may tilt one even more into imbalance, may not properly support good health. Heck, I could have told you that before all this media fuss. But, with enough vitamin D the problem magically disappeared!. Supplementation of vitamin D apparently re-established good calcium metabolism, even at high levels of intake. The true issue then isn’t so much related to variations in calcium and vitamin D supplies, not to mention the unknown availability of other essential bone nutrients. It’s the misapplication of a drug model to a nutrient while ignoring known variables that affect the body’s proper use of that nutrient. One shouldn’t give a lot of calcium to those with adequate dietary intake, nor to those with insufficient vitamin D (and K, magnesium, et al) intake. This type of thought process is elementary to a nutritionist, of course, but apparently not to the well credentialed authors of many flawed drug model meta-analyses and their often overreaching conclusions.

You may be interested to know that a world-class researcher who has been working on calcium metabolism and osteoporosis for more than 50 years, the respected scientist who drafted the World Health Organization’s dietary calcium recommendations, strongly opposed the conclusions of the current calcium meta-analysis. Professor Chris Nordin from the Royal Adelaide Hospital in Australia was interviewed by ABC News. This news report cited Professor Nordin as saying that the meta-analysis was misleading because it improperly included studies involving a mixture of men and women, and the findings were not statistically significant. "Men are much more liable to heart attacks than women but women need calcium far more than men, so it is absurd to publish a study of the effect of calcium on the heart without separating men from women," he was quoted. Professor Nordin noted the fact that calcium supplements are predominantly recommended for and used by postmenopausal women because their bone loss is due to an increase in bone breakdown, which responds well to calcium supplementation (and vitamin D, if necessary). But he reports that calcium is seldom recommended for elderly men because their bone loss has a different cause, which is seldom caused by a need for more of that mineral. "Concluding that calcium supplements can lead to a 30 per cent increase in heart attack risk is quite premature and alarmist and can only set back the cause of osteoporosis prevention which should be our primary objective," he said.

According to ABC News, Osteoporosis Australia has also questioned the findings of the meta-analysis because many long-term studies have shown calcium supplements are safe and effective. In a statement posted on its website, Osteoporosis Australia says the weight of evidence to date indicates no increased risk of heart attacks from taking calcium supplements, which it says are an effective way of reducing fracture risk and bone loss in older men and women who have diets low in calcium.

This should point out the folly of well-meaning researchers who design studies to investigate topics that they don’t properly understand. In those cases, they simply don’t realize that there are other essential factors that can change everything and require a completely different and more comprehensive study design. That’s par for the course when meta-analyses are used to sort through previously published nutrient studies. Basic design flaws often make meta-analyses fatally flawed, despite the apparently sophisticated mathematical models and methods that researchers incorrectly try to apply to the data. Is it any wonder that we’re so confused about nutrition when researchers gain worldwide prominence for issuing highly questionable sensational reports that contradict the scientific consensus - but never have to say they’re sorry?

Calcium does not cause more heart attacks in well-designed primary human clinical studies. Healthy people should not be concerned about taking essential nutrients just because certain studies were flawed or performed on sick or at-risk populations and may have had negative results. Many of those negative reports have been challenged and may not have been verified and replicated in well designed clinical trails. The conclusions of such reports are sensational and well publicized precisely because they seem to negate our previous scientific consensus; which should make them more, not less, suspect. But the modern news cycle seems to thrive on such controversy, without caring how confused we get about what’s healthy and what’s not. But don’t worry; you have Honest Nutrition to help you sort it all out!

REFERENCES:

Bolland MJ, Avenell A, Baron JA, Grey A, Maclennan GS, Gamble GD, Reid IR. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ. 2010 Jul 29;341:c3691. doi: 10.1136/bmj.c3691. PubMed PMID: 20671013.

http://www.bmj.com/cgi/content/full/341/jul29_1/c3691?view=long&pmid=20671013

http://www.abc.net.au/news/stories/2010/08/03/2972399.htm?section=justin

How Nutrition Affects Swine Flu (Influenza) and Immunity

Why are the Public Health authorities silent on the role of nutrition to protect us during an official national health emergency? Do they not know, or simply not care? Is either answer acceptable to citizens concerned about their health and wanting to get practical/real/fair/impartial information that we can utilize to help protect our families? Here's what the experts are not telling us:

• Did you know that if you had the seasonal flu vaccine last year it may make you more vulnerable to the swine flu this year? Vaccines create antibodies that actually make you more susceptible to other organisms, like viruses and bacteria. (Four Canadian studies reported by CBC News, 9/23/09)
• Did you know that side effects of vaccines can be minimized if there are adequate levels of vitamin D in the person? (Epidemic influenza and vitamin D. Epidemiol Infect. 2006 Dec;134(6):1129-40. Review.)
• Did you know that a lack of vitamin D makes people far more likely to have respiratory infections? (On the epidemiology of influenza. Virol J. 2008 Feb 25;5:29. Review.) Did you know that the virus itself can become less aggressive and less prone to mutating into more dangerous forms if a person has adequate levels of nutrients, especially antioxidants? (Host nutritional status: the neglected virulence factor. Trends Microbiol. 2004 Sep;12(9):417-23. Review.)
• Did you know that antioxidants, like selenium, not only reduce our vulnerability to getting influenza but also reduce the chances that it will progress into pneumonia! (Host nutritional status: the neglected virulence factor. Trends Microbiol. 2004 Sep;12(9):417-23. Review.)

How are vitamins C, D and K in supplements made?

Almost all D’s on the market are nature-identical synthesized forms. D3 and D2 are both naturally occurring in foods, but in supplements the same forms are usually from synthesized sources. So D3 synthesized from sheep lanolin is no more natural than D2 from plants or fungi. In fact, the D3 made in the skin-liver-kidneys from cholesterol and sunlight is also literally synthesized. Either plant sterols or animal sterols (cholesterol in humans, lanolin from sheep) are irradiated with UV-B light to make D2 or D3, respectively. It is a synthetic process, either internally or to produce the supplemental form; in much the same way that vitamin C can be synthesized by most mammals (not humans) from blood glucose in a process that mirrors the commercially synthesized nature-identical form. By the way, Vitamin K is also synthesized as the exact same form found in green foods (K1). Fermented foods like cheese can also contain K2 (MK-4), which is synthesized by microbes like bacteria.

Natural Health: Ten Predictions for the Year 2008

Natural Health: Ten Predictions for the Year 2008 By Neil E. Levin, CCN, DANLA 12/10/2007 The New Year will bring more proof of antioxidant benefits for human health. Recent research shows that antioxidants help to maintain healthy brain functions during aging, protect brain and nerve cells, and prevent hormones and cholesterol fractions from oxidizing to become more harmful forms. Look for an expanded understanding of the benefits of these synergistic nutrients in 2008. 2008 will provide more proof of omega-3 fatty acids’ benefits. For example, DHA helps to maintain healthy balances of cholesterol fractions and protects the brain and nerves. EPA helps normalize cell membranes and cellular health. These essential fats are typically very low in the American diet, so dramatic results could occur in clinical trials providing these nutrients to participants. There will be more safety scares regarding popular prescription and Over-The-Counter drugs, creating new safety warnings and label cautions. Since the most popular medications are typically blocking or inhibiting natural body functions (calcium channel blockers, cholesterol production inhibitors, serotonin re-uptake inhibitors, stomach acid production inhibitors, etc.) rather than dealing holistically with the causes of problems that create body imbalances (lack of optimal levels of nutrients, environmental chemicals and metals, chronic stress - lack of deep sleep, low fiber - high carbohydrate diets, etc.), major side effects from such drugs are inevitable. Side effects from pain medications will become more evident, increasing the number of people looking for safer alternatives. Herbs and spices are the major natural alternatives with some scientific evidence of efficacy. The market for organic and local foods will continue to grow at amazing levels. This will put pressure on the regulatory, farm and grocery industries to manage these products and segregate them to maintain their integrity. That contrasts with the increased reliance on genetically engineered corn to produce ethanol that raises food costs and increases the use of farm chemicals. And there is much evidence that non-genetically engineered foods are both environmentally and nutritionally superior to their modified cousins, while natural farming techniques are proving superior to chemical and genetically engineered farming in terms of managing fuel and seed costs, water use, improving both crop yields and selling prices, etc. Millions of farmers around the world have already weaned themselves from the chemical-genetic “green revolution” to use appropriate local farming techniques and have actually been more successful as a direct result of truly “green” practices. America has begun to awaken to the benefits of local and organic foods in terms of freshness, reducing the use of fossil fuels for transportation and demonstrable benefits to local economies. Watch for these trends to accelerate in 2008. Blood pressure and blood sugar concerns will continue to grow, along with a medical backlash attacking natural strategies to manage these concerns. However, science will also continue to amass evidencing the positive health benefits of natural products to help people maintain already healthy blood levels, in contrast with the poor symptom management that is a characteristic of pharmaceutical or surgical interventions used to “correct” chronic biological imbalances. These issues dovetail with current obesity and cardiovascular concerns and are part of the same syndrome related to chronic stress and poor diets. Positive reports of the benefits of higher levels of vitamin D will continue to proliferate, though with some bias against the synthesized vegetarian/vegan form of vitamin D2 versus D3 from fish oil or sheep lanolin. Health authorities will be pressured to raise both the recommended Daily Value and the Upper Limit of vitamin D to five times the current levels. Research will continue to accumulate regarding the health benefits of whole grains and whole foods, as will reports of people allergic or sensitive to gluten, corn, and other grains. More mainstream processed groceries will have whole food options in 2008. This is a good trend, though with cautions for the sensitive minority. There will be continuing claims that “dietary supplements” are illegally contaminated with steroids or other pharmaceutical drugs. These claims will typically be self-serving and defensive, made primarily by athletes accused of cheating by using banned substances. Beyond the obvious fact that legitimate supplement manufacturers do not have illegal substances on hand and that GMP (Good Manufacturing Practices certification) quality manufacturing protocols would avoid inadvertent contamination, these accusations are a barometer of how “unregulated” the mainstream media and the public thinks dietary supplements are. While there are plenty of regulations written specifically to regulate supplements, and even the FDA claims that it has adequate regulatory authority, somehow certain medical authorities and journalists like to pretend otherwise; perhaps to have a handy punching bag to deflect attention from the well-documented hundreds of thousands of deaths caused annually from pharmaceuticals and medical errors. In any case, expect more of this blame game in 2008. With a presidential election campaign under full swing, no meaningful legislation regarding health care or Medicare will be passed in 2008. There will be a narrow window of opportunity for such measures in 2009 with a new Congress and Administration. Natural health advocates will continue to press for meaningful use of nutrition to combat the major causes of disease and illness in America, with probably little impact against the lobbying might of the medical and pharmaceutical interests. The wild card is if, by some miracle, the insurance industry finally notices that their costs could be contained by the use of targeted nutrition such as the use of calcium and vitamin D to prevent osteoporosis, antioxidants to prevent age-related macular degeneration and oxidative-related glaucoma that affect vision and impact seniors’ independence, omega-3 fats to prevent coronary heart disease, the use of fiber to manage healthy cholesterol levels, etc. That could swing the pendulum towards the use of natural products to control healthcare costs. But I’m not betting on it happening in 2008, though I hope that they wise up soon enough to manage the recently overactive increases in medical costs. There will be additional, unjustified health scares about essential nutrients in 2008. Especially beware of “meta-analyses” that mix unrelated studies and magnify the number of variables using often-flawed statistical models. Some probable targets: · Kava (a few unrelated, anecdotal reports of liver problems) · Folic acid (a few reports of higher cancer levels despite a lot of cellular data indicating the opposite, creating a backlash against re-fortification of refined foods) · Vitamin E (continued championing/publicity of questionable meta-analyses over more rigorous blood-level studies will continue the inexplicable controversy over the safety of this essential nutrient that most Americans are reportedly deficient in.) · Beta-Carotene (again, blood level studies and total antioxidant studies repeatedly show its safety, but studies measuring only administration of certain doses to sick populations that may be deficient in antioxidants create a conflicting picture.) · DHEA (this adrenal hormone has been vilified as a “steroid”, but is no more so than vitamin D. No less an authority than physician and US Senator Tom Coburn has sent a letter to his colleagues informing them that he has reviewed the issues and urging them to avoid a ban of this natural product, which is useful in anti-aging strategies but not for bodybuilders. Efforts by leading senators (including presidential candidates Clinton and McCain) to ban DHEA are ongoing.

BMJ finding on calcium and D "failure" questionable

A 25% reduction in the number of fractures was not considered significant in this study, calling into question the statistical model and study design. They did not find "no evidence" of the supplements' effectiveness, as cited, but rather found no significant evidence. Why? Thus creating the "failure" of the supplements. (Click on title to read the journal article.)