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.

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

The critical condition of patients admitted to the ICU is associated with worsening oxidative stress.

The critical condition of patients admitted to the ICU is associated with worsening oxidative stress, according to a medical journal article. "A major finding of the study was that administration of antioxidant vitamins at between 66% and 100% of RDA can reduce the risk for oxidative stress by 94%..." "...dietary enteral supplementation with vitamins C and E for 10 days prevented lipid peroxidation and oxidative stress in critical care patients and significantly influenced their clinical outcome at 28 days." "Greater depletion of antioxidants has been related to a greater severity of trauma, systemic inflammatory response syndrome, or sepsis." full article is available at: http://ccforum.com/content/10/5/R146

A Tale of Two Studies: Vitamin E - Food vs Supplements

Vitamin E: Food vs Supplements Here is an illustration of the apparent contradiction between whether food sources of vitamin E are better to prevent prostate cancer than supplemental vitamin E sources: Two large studies, both published in the same technical journal at the same time, seem to reach contradictory results as to whether supplemental vitamin E is valuable in relation to prostate cancer. But are they both equal and contradictory? Actually, one is far more rigorous, and thus presumably more valid, than the other. In the first one (Serum and Dietary Vitamin E in Relation to Prostate Cancer Risk <1>), definite and large benefits were shown for supplemental alpha-tocopherol vitamin E, but not for food sources (containing mostly gamma-tocopherol). In the second one (Supplemental and Dietary Vitamin E Intakes and Risk of Prostate Cancer in a Large Prospective Study <2>), only food sources containing gamma-tocopherol were effective, but not supplemental vitamin E as alpha-tocopherol. A closer look reveals that the first study responsibly looked at serum levels and food plus supplemental vitamin E intake, then related that data to prostate cancer rates over up to 19 years afterward. This study's conclusion was that, "In summary, higher prediagnostic serum concentrations of alpha-tocopherol, but not dietary vitamin E, was associated with lower risk of developing prostate cancer, particularly advanced prostate cancer." The second study looked only at questionnaires related to subjects' intake of vitamin E from food and supplements at the start of the 5-year study, then compared the number of cancers over a 5-year period to data obtained from that questionnaire. The incubation period for cancers is estimated to be in the decades, rarely a period of 5 years or less. That, along with the lack of any data on serum antioxidant status and the use of a questionably reliable survey to determine intake of vitamin E from food or supplements, makes the second report far less meaningful than the first one. Don’t get me wrong, I am not against food sources of nutrients and routinely recommend vitamin E sources containing gamma-tocopherol, along with the full range of tocopherols and tocotrienols. But when preliminary or sketchy science is all-too-often reported as if it’s definitive when it’s really not, and when it is contradicted by better science, I am compelled to put things into a more realistic perspective. The measurement of serum levels in the body, along with careful reporting of a nutrient’s intake from various sources, is much more compelling than relying on a questionnaire that may be done by memory. It is well-known among nutritionists that daily food diaries are notoriously different than weekly food surveys done by memory recall, which almost always seem to conveniently forget the junk food, snacks and extra calories. A cancer study lasting nearly 4 times as long is also far more compelling than a shorter one because it will be more likely to encompass the cancer’s incubation period and allow for the development of symptoms that will allow detection. As the National Cancer Institute reports: “Prostate cancer often does not cause symptoms for many years.” <3> The use of supplemental alpha-tocopherol is supported by other reputable studies. For example, The Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study demonstrated a 32% reduction in prostate cancer incidence in response to daily alpha-tocopherol supplementation. <4> Levels of Vitamin E above 100 IU daily are associated with decreased risk of coronary heart disease and certain types of cancer, as well as enhancement of immune function. These increased vitamin E intakes (100 I.U. and above) are considerably above levels obtainable from diet alone. <5-7> In the case of supplemental vitamin E, the results for prostate cancer in the more rigorous, better designed and better implemented study shows that it is more beneficial for prostate health than only food sources of vitamin E, which also tend to be much weaker amounts (often far below 100 IU daily, with Americans’ typical intake being only around 9.5 IU (6.4 mg) of alpha-tocopherol, below the RDA of 22.5 IU (15 mg). <8-9> This indicates our general need for supplemental vitamin E, unless by some miracle we all suddenly decide to eat wholesome natural foods containing a lot more vitamin E. But in the meantime, it would be nice if these studies were put into perspective so we could accurately assess their value to our health habits. Unfortunately, media coverage of negative reports, especially regarding vitamins, tends to drown out the positive ones, even when the good news is backed by studies with better design and implementation. In this case, supplemental vitamin E was the clear winner over the abysmal amounts in our diet, which ideally should be increased to healthy levels. REFERENCES: 1. Weinstein, SJ, et al. Serum and Dietary Vitamin E in Relation to Prostate Cancer Risk. Cancer Epidemiol Biomarkers Prev 2007 16: p. 1253-1259 http://cebp.aacrjournals.org/cgi/content/abstract/16/6/1253?ct 2. Wright, ME, et al. Supplemental and Dietary Vitamin E Intakes and Risk of Prostate Cancer in a Large Prospective Study. Cancer Epidemiol Biomarkers Prev 2007 16: p. 1128-1135 http://cebp.aacrjournals.org/cgi/content/abstract/16/6/1128?ct 3. National Cancer Institute’s Web site http://www.cancer.gov/cancertopics/factsheet/Detection/early-prostate 4. Weinstein SJ, et al. Serum alpha-tocopherol and gamma-tocopherol in relation to prostate cancer risk in a prospective study. J Natl Cancer Inst. 2005 Mar 2;97(5):396-9. PMID: 15741576 5. Bauernfeind, J. Tocopherols in Foods. In: Vitamin E: A Comprehensive Treatise. Marcel Dekker, Inc., New York and Basel, pp. 99-167, 1980 6. Horwitt, M.K. The Promotion of Vitamin E. J. Nutr. 116:1371-1377, 1986 7. Weber, P., Bendich, A. and Machlin, L.J. Vitamin E and Human Health: Rationale for Determining Recommended Intake Levels. Nutrition 13:450-460, 1997 8. Ervin RB, Wright JD, Wang CY, Kennedy-Stephenson J. Dietary intake of selected vitamins for the United States Population: 1999–2000. Advance data from vital and health statistics; no 339. Hyattsville, Maryland: National Center for Health Statistics. 2004 9. Vitamin E, Office of Dietary Supplements • NIH Clinical Center • National Institutes of Health http://ods.od.nih.gov/factsheets/vitamine.asp

Natural Causes is cause for concern about journalism

Natural Causes To those deciding whether this book is worthy of purchasing, I find that many of the author's claims are overblown. Some are demonstrably untrue. Mr. Hurley's inflammatory rhetoric is apparently at odds with official FDA statements, because on its website and in Congressional testimony the agency has repeatedly stated that it has adequate power to regulate dietary supplement safety and quality, which the author denies is true. DSHEA (the Dietary Supplement Health and Education Act) is NOT a deregulation bill. It took a misunderstood food category and elevated its regulation to almost that of pharmaceuticals, allowing the FDA to ban drug and disease claims, control manufacturing quality through mandatory Good Manufacturing Practices (GMP), have veto power over label claims, and make manufacturers bear responsibility for mislabeled, adulterated or unsafe products. What was stopped by DSHEA was inexplicable FDA harassment of supplements, stopped only by outraged federal judges. DSHEA was the compromise bill that gave more power to the FDA while preventing the grossest abuses of its power. Dietary supplement plants are FDA inspected, while also under the sanitation and health laws of local and state governments. Other quality inspectors keep manufacturers honest; for example, GMP, organic and kosher certifiers. A documented paper trail is required for every step in the production of products. The FTC also regulates dietary supplement advertising, including monitoring Internet websites. The dietary supplement industry strongly supported the recent Adverse Event Reporting Act that requires manufacturers to report all serious adverse events to the FDA. Some manufacturers have already been doing this voluntarily, but have received very few, to date. This evidences their commitment to safety. Dietary supplement industry associations have quality programs that require registration and random testing for active ingredients in products, so member companies are of a significantly higher level of quality assurance than other manufacturers. Of course, not all natural products are 100% safe or 100% effective for every person. But, checking poisoning death figures from the American Association of Poison Control Centers, I see that supplements are safer than most other products: there were only 5 accidental deaths linked (reported as possibly due) to dietary supplements over a 3-year period. In the same 3-year reporting period, there were 67 deaths from plain aspirin, 50 from aspirin combinations, 48 from pesticides, 7 from cosmetics, 66 from household cleaners, 171 from plain acetaminophen, and 446 from acetaminophen combinations. The medical journal JAMA reports that there are over 100,000 deaths a year from pharmaceutical drugs that are used as directed, and many more from misperceived drugs. How many dies from the FDA-approved drug Vioxx? How many from mood altering and cholesterol lowering drugs? How many from cardiovascular disease aggravated by synthetic hormone replacement therapy? The tryptophan that caused deaths in the late 1980's was reportedly produced by a pharmaceutical company using a prototype/unproven genetically engineered bacteria for the first time to produce the amino acid, which was then prescribed by a physician. How do dietary supplement companies get all the blame for this? While Mr. Hurley is correct that, normally, food is the best source of nutrients, there are some that are shown to be better absorbed from supplements than food, such as certain B vitamins. Compared with the admitted shortage of essential nutrients in the American diet and the dangers of prescribed and OTC drugs, most people feel better about the relative safety and utility of dietary supplements. Greater than RDA levels of vitamins are NOT toxic. Safe upper levels exist and are often far higher. Medical professionals frequently use mega-doses of Vitamin C, biotin, folic acid, vitamin B-12 and vitamin D with no serious adverse effects. Natural products companies exist because of a strong commitment to natural health, including product safety. Most natural products manufacturers would rather go out of business than harm their customers. Many people believe that natural products are more health promoting than synthetic drugs because the nutrients and gentler therapeutic agents are better tolerated by the body and encourage healing; not merely controlling symptoms like so many toxic drugs. And, yes, dietary supplements are backed by tens of thousands of published research papers showing their safety and efficacy. I read them daily. Perhaps Mr. Hurley just didn't pay enough attention in science class and is too focused on muckraking to notice his many errors. I give this book an "F". Neil E. Levin, CCN, DANLA board certified clinical nutritionist with diplomate in advanced nutritional laboratory assessment http://www.honestnutrition.com/