by Ian Wishart
Hence, if you want to optimize your vitamin D levels – not just optimize the bone effect – supplementing is crucial. But it is almost impossible to significantly raise your vitamin D levels when supplementing at only 600 IU/day (15 micrograms).
Pregnant women taking 400 IU/day have the same blood levels as pregnant women not taking vitamin D; that is, 400 IU is a meaninglessly small dose for pregnant women. Even taking 2,000 IU/day of vitamin D will only increase the vitamin D levels of most pregnant women by about 10 points, depending mainly on their weight. Professor Bruce Hollis has shown that 2,000 IU/day does not raise vitamin D to healthy or natural levels in either pregnant or lactating women. Therefore supplementing with higher amounts – like 5000 IU/day – is crucial for those women who want their fetus to enjoy optimal vitamin D levels, and the future health benefits that go along with it.
For example, taking only two of the hundreds of recently published studies:
Professor Urashima and colleagues in Japan, gave 1,200 IU/day of vitamin D3 for six months to Japanese 10-year-olds in a randomized controlled trial. They found vitamin D dramatically reduced the incidence of influenza A as well as the episodes of asthma attacks in the treated kids while the placebo group was not so fortunate. If Dr. Urashima had followed the newest FNB recommendations, it is unlikely that 400 IU/day treatment arm would have done much of anything and some of the treated young teenagers may have come to serious harm without the vitamin D.
Likewise, a randomized controlled prevention trial of adults by Professor Joan Lappe and colleagues at Creighton University, which showed dramatic improvements in the health of internal organs, used more than twice the FNB’s new adult recommendations.
Finally, the FNB committee consulted with 14 vitamin D experts and – after reading these 14 different reports – the FNB decided to suppress their reports. Many of these 14 consultants are either famous vitamin D researchers, like Professor Robert Heaney at Creighton or, as in the case of Professor Walter Willett at Harvard, the single best-known nutritionist in the world. So, the FNB will not tell us what Professors Heaney and Willett thought of their new report? Why not?
Today, the Vitamin D Council directed our attorney to file a federal Freedom of Information (FOI) request to the IOM’s FNB for the release of these 14 reports.
Most of my friends, hundreds of patients, and thousands of readers of the Vitamin D Council newsletter (not to mention myself), have been taking 5,000 IU/day for up to eight years. Not only have they reported no significant side-effects, indeed, they have reported greatly improved health in multiple organ systems.
My advice, especially for pregnant women: continue taking 5,000 IU/day until your 25(OH)D is between 50–80 ng/mL (the vitamin D blood levels obtained by humans who live and work in the sun and the mid-point of the current reference ranges at all American laboratories).
Gestational vitamin D deficiency is not only associated with rickets, but a significantly increased risk of neonatal pneumonia, a doubled risk for preeclampsia, a tripled risk for gestational diabetes, and a quadrupled risk for primary cesarean section.
Today, the FNB has failed millions of pregnant women whose as yet unborn babies will pay the price. Let us hope the FNB will comply with the spirit of “transparency” by quickly responding to our Freedom of Information requests.
John Jacob Cannell MD, Executive Director
It didn’t actually take long for deep and far reaching criticisms of the Institute of Medicines report to emerge especially since, as Cannell alluded to, it had been peer reviewed by leading vitamin D specialists and found wanting.
One of those peer reviewers, Creighton University’s Robert Heaney, was lead signatory on a letter in the medical press tearing the IOM report apart, in the restrained fashion that medical professionals are used to:[14]
“The Commentary by Ross et al.,[15] concerning the recent calcium and vitamin D recommendations of the Institute of Medicine (IOM) has the potential to be substantially misleading. First, the title (“What clinicians need to know”) is incorrect. The focus of all recommendations from the Food and Nutrition Board is, as the text of the article states, “normal healthy persons”. Those recommendations have no applicability for patients with disease, or for physicians attempting to prevent disease in at-risk populations. That distinction is something clinicians need to know.
“The Commentary also gives no hint of the substantial dissent which the recommendations have evoked from the vitamin D investigative community. The draft report had been submitted to external experts, and it is to be presumed that their findings were made available to the panel.
“While the details of these reviews are shrouded behind a pledge of secrecy, it is clear from the published comments of several of them that the review uncovered errors both factual and strategic/analytic. Some acknowledgement of this dissent would have been useful. One infers that there must also have been dissent within the panel itself, as one of its members was a co-author of Canadian guidelines[16] which specifically recommended cholecalciferol intakes approximately three times higher than the IOM. Thus, rather than being a settled issue, clinicians need to know that the IOM recommendations do not represent a consensus.
“There is not room here to recount the many factual errors in the IOM report, some described elsewhere.[17] But two in particular are, we judge, suggestive of how the panel approached evidence…”
What followed were highly-technical discussions laced with juicy phrases like “osteoid volume (OV/BV) above 1% for 25(OH)D > 32 ng/mL,” or “Nevertheless the IOM panel accepted 20 ng/mL as the lower bound of normal, despite the fact that approximately half of the individuals between 20 and 32 had OV/BV values above 1% (and ranging up to 4.5%)…”
In the end, the accusation appeared to come down to one of politics:
“In both instances, there seemed to have been an effort to discredit or distort studies that were incompatible with the panel’s proposed 20 ng/mL lower bound for normal vitamin D status.
“Finally, in their conclusion, Ross et al. call for more randomized controlled trials. This is such a part of the conventional wisdom that it would seem to be entirely reasonable. Instead it dodges the panel’s responsibility to deal with the available evidence. Most of the “needed” randomized trials are simply unfeasible (8), as they would require low intake contrast groups with serum 25(OH)D levels below even the IOM’s already low recommendation. Such trials would be unethical. Since they cannot be done, this purported “need” leaves critical nutritional policy issues in a kind of permanent limbo.”
In medical science, ‘them’s fightin’ words’.
Researcher Dr William Grant waded in, noting that the IOM had cherry-picked studies it liked, and ignored randomized controlled trials it didn’t like, such as the ones you’ve read in this book:
“The committee appeared to have a bias of excluding RCTs on such outcomes as cancer and influenza incidence and effects during pregnancy that were not in line with its eventual recommendations,” said Grant in a 2012 review.[18]
“This report has been severely criticized by the vitamin D research community, with over 125 journal publications to date disagreeing with the recommendations. A representative paper stated: ‘The IOM recommendations for vitamin D fail in a major way on logic, on science, and on effective public health guidance. Moreover, by failing to use a physiological referent, the IOM approach constitutes precisely the wrong model for development of nutritional policy.’[19]
“The case could be made that the IOM committee, by setting the recommended dose so unreasonably low, is putting the U.S. population at greatly increased health risk. Further, much of the rest of the world’s countries look to the IOM report for guidance, placing a major portion of the world’s population at risk.”
Weighing up the Institute of Medicine’s “prove it” position, researchers went back and tested the thousands of studies already done: Is there sufficient evidence already on the table to justify high-dose vitamin D as a
preventative? Their conclusion: there is, and people probably shouldn’t wait for official advice before acting.[20]
“A wide range of epidemiologic and laboratory studies combined provide compelling evidence of a protective role of vitamin D on risk of breast cancer. This review evaluates the scientific evidence for such a role in the context of the A.B. Hill criteria for causality, in order to assess the presence of a causal, inverse relationship, between vitamin D status and breast cancer risk.
“After evaluation of this evidence in the context of Hill’s criteria, it was found that the criteria for a causal relationship were largely satisfied.
“Studies in human populations and the laboratory have consistently demonstrated that vitamin D plays an important role in the prevention of breast cancer.
“Vitamin D supplementation is an urgently needed, low cost, effective, and safe intervention strategy for breast cancer prevention that should be implemented without delay. In the meantime, randomized controlled trials of high doses of vitamin D3 for prevention of breast cancer should be undertaken to provide the necessary evidence to guide national health policy.”
In June 2012 the Endocrine Society published its own statement on vitamin D, noting “strong association” between the vitamin and a range of health issues as outlined in this book. However, with a lack of randomised controlled trials in many areas, the Society could not step ahead of the evidence and make across the board recommendations.[21]
“Although future research may demonstrate clear benefits for vitamin D in relation to cancer and possibly support higher intake requirements for this purpose, the existing evidence has not reached that threshold.
“There is emerging evidence that vitamin D may directly regulate immune function, both innate and adaptive. However, it will require large well-designed clinical trials to prove that vitamin D supplementation could enhance innate immunity or reduce the severity of autoimmunity.
“In summary, not surprisingly there remains a persistent need for large randomized controlled trials and dose response data to test the effects of vitamin D on chronic disease outcomes including autoimmunity, obesity, diabetes mellitus, hypertension, and heart disease.”
The problem is, randomised controlled trials are expensive. Normally they are done by drug companies with a patented drug that they can then sell for billions under licence as part of recouping the research costs. Vitamin D on the other hand is non-patentable, natural and cheap. Pharmaceutical companies are not exactly falling over themselves to fund full vitamin D3 trials for two reasons. 1, they make no money. 2, if they prove that vitamin D3 does improve your health to the extent now believed by researchers, that could represent a massive fall in profits for pharmaceutical companies in the face of sliding demand for their medicines. Which may be the reason some in the medical establishment are dragging their heels on vitamin D as well.
There is also the reality, as you’ve seen in this book, that some randomized human trials would quite simply be unethical. We cannot starve a baby or a foetus of vitamin D in a double-blind trial. There are therefore considerable areas of research where we cannot push research to the nth degree, but only rely on observational studies after the fact.
Despite the crying need for randomised trials, few have been undertaken:
“The function and requirement of vitamin D during pregnancy for both mother and fetus have remained a mystery. This fact was highlighted by The Cochrane Review in 2000, which reported a lack of randomized controlled trials (RCTs) with respect to vitamin D requirements during pregnancy. Unfortunately, during the past decade only a single RCT has been performed with respect to vitamin D requirements during pregnancy.”[22]
That study, incidentally, was performed by vitamin D researchers on their own initiative. The bottom line appears to be a simple choice: do we as members of the public begin boosting our vitamin D levels on the basis that it can’t do any harm to bring them up to where nature expects them to be, or should we sit and wait for the health bureaucracy?
[1] “Place mushrooms in sunlight to get your vitamin D: part one,” Paul Stamets, Huffington Post, 2 July 2012
[2] “Western Australia gets vitamin D enhanced mushrooms,” 6 July 2012 www.freshplaza.com/print.asp?id=97180
[3] The Institute of Medicine lists these levels as “safe”, but the RDI is set much lower
[4] This also goes to the “breast is best” feeding argument. It is, but only if the mother has the proper reserves in her system of vitamin D. A 500IU dose from a pregnancy vitamin is not going to protect your baby or you. Breastfed babies are now a recognised risk group for vitamin D deficiency and rickets.
[5] “Randomised comparison of the effects of the vitamin D adequate intake vs 100mcg (4000IU) per day on biochemical responses and the wellbeing of patients,” Vieth et al, Nutrition 2004; Nutr J. 2004; 3: 8.
Published online 2004 July 19. doi: 10.1186/1475-2891-3-8, see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC506781/
[6] “The vitamin D epidemic and its health consequences,” Holick MF, Journal of Nutrition 2005; 135:2739S-2748S
[7] http://www.mdpi.com/2072-6643/4/3/208/htm
[8] “Developmental vitamin D deficiency alters brain protein expression in the adult rate: implications for neuropsychiatric disorders,” Almeras et al, Proteomics, 2007; 7:769-780. See also “Developmental vitamin D3 deficiency alters the adult rat brain,” Feron et al, Brain Res Bull 2005; 65:141-148, and also “Vitamin D deficiency during various stages of pregnancy in the rat; its impact on development and behaviour in adult offspring,” O’Loan et al, Psychoneuroendocrinology 2007; 32:227-234
[9] “Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant,” Hollis et al, American Journal of Clinical Nutrition, 2004; 79:717-726
[10] Having said that, doctors have deliberately dosed multiple sclerosis patients to bring their blood levels to an average of 154 ng/ml, with no negative effects during the 28 week trial. See “Safety of vitamin D3 in adults with multiple sclerosis,” Kimball et al, American Journal of Clinical Nutrition 2007; 86:645-651
[11] “Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency: efficacy and safety data,” Diamond et al, Med J Aust 2005; 183:10-12
[12] “Efficacy of an oral, 10-day course of high-dose calciferol in correcting vitamin D,” Wu et al, N Z Med J. 2003 Aug 8;116(1179):U536. deficiency
[13] http://www.iom.edu/Reports/2010/Dietary-Reference-Intakes-for-Calcium-and-Vitamin-D.aspx
[14] http://jcem.endojournals.org/content/96/1/53/reply
[15] Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA 2011 The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab 96:53-58
[16] Hanley DA, Cranney A, Jones G, Whiting SJ, Leslie WD, Cole DEC, Atkinson SA, Josse RG, Feldman S, Kline GA, Rosen C 2010 Vitamin D in adult health and disease: a review and guideline statement from Osteoporosis Canada. CMAJ 182: [Epub ahead of print Sept 7, 2010.]
[17] “Why the IOM recommendations for vitamin D are deficient,” Heaney RP, Holick MF 2011. J Bone Miner Res (in press) March 2011 [Epub ahead of print 1/5/11.]
4. “The D-batable Institute of Medicine report: A D- lightful perspective,” Holick MF 2011. Endocr Prac 17:143-149
[18] “Top Vitamin D Papers of 2011 – Dosage Recommendations and Clinical Applications,” William B. Grant, Ph.D, April 10, 2012, http://orthomolecular.org/resources/omns/v08n12.shtml
[19] “Why the IOM recommendations for vitamin D are deficient,” Heaney RP, Holick MF.. J Bone Miner Res. 2011;26(3):455-7
[20] “Does the evidence for an inverse relationship between serum vitamin D status and breast cancer risk satisfy the Hill criteria?”, Mohr et al, Dermato-Endocrinology, Volume
4, Issue 2 April/May/June 2012, http://www.es.landesbioscience.com/journals/dermatoendocrinology/2012DE0186.pdf
[21] Rosen et al, Endocrine Reviews, June 2012, 33(3):456–492
http://edrv.endojournals.org/content/33/3/456.full.pdf+html
[22] “Vitamin D and Pregnancy: Skeletal Effects, Nonskeletal Effects, and Birth Outcomes,” Hollis & Wagner, Calcified Tissue International, 2012, DOI: 10.1007/s00223-012-9607-4
CHAPTER 16
THE NZ POSITION: A COMMENTARY
“The Ministry of Health says supplements aren’t necessary”
– NZ Listener, 2012
There are big discrepancies between what is regarded as a deficient vitamin D intake and what is not. Deficiency was defined in the 2002 Children’s Nutrition Survey as less than 17.5 nmol/L of vitamin D in blood (8 ng/ml),[1] whereas the international Vitamin D Council would classify that as “seriously deficient”.
The now internationally accepted “seriously deficient” level of less than 25 nmol/L (10 ng/ml) is classified by New Zealand authorities as only “moderately deficient”, and even “deficient” doesn’t kick in here until it’s below 17 nmol/L (7 ng/ml).[2] Is this Orwellian newspeak or simply a reflection of the mental acuity of the Wellington health bureaucracy? It appears to be the latter.
Because New Zealand’s Ministry of Health is still in denial after seven years about the benefits of vitamin D in fighting anything but rickets, it still defines vitamin D ‘adequacy’ in skeletal health terms, which is a strategic mistake.[3] Bones require much lower doses of vitamin D to maintain good bone health, meaning just because you have “adequate” vitamin D in that area, does not mean you have enough vitamin D to fight cancer or heart disease.