The Institute of Medicine’s new Vitamin D and Calcium guidelines, released late in November, sent shockwaves through the natural health care and integrative medicine community. The IOM review committee asserted that most Americans do not need vitamin D supplements, that 600 IU/day is sufficient for maintaining healthy bones, and that there’s no firm evidence that supplementation beyond that level has health benefits aside from bone health.
The committee's positions took many nutrition-focused clinicians by surprise because it runs directly counter to a swelling tide of epidemiologic, observational and case-control evidence that vitamin D in doses as high as 1,000-5,000 IU daily, could reduce risk of heart disease and various cancers, and ameliorate depression, diabetes, MS, autism, and other common diseases. The IOM committee deliberately excluded observational and epidemiological studies from its analysis, contending that while such studies may be suggestive, they are inconclusive at best, misleading at worst. (Read the IOM report online, free of charge: http://books.nap.edu/openbook.php?record_id=13050)
Shortly after the IOM report was published, we asked the Holistic Primary Care clinical community to share thoughts on the new guidelines. The opinions and viewpoints are diverse and interesting, to say the least! We welcome your comments & reflections on the new Vitamin D RDI's.
Here’s what a few community members had to say:
Katherine Crew, MD, Ass’t Professor of Medicine & Epidemiology, New York Presbyterian Hospital-Columbia University Medical Center; author of several studies on vitamin D & breast cancer risk:
I read the IOM report and I do believe they took a conservative approach in terms of making broad recommendations for the general public, in spite of the extensive published research on vitamin D--mainly epidemiologic association studies. This highlights the fact that much is still unknown about the potential role of supplementation for preventing a number of chronic diseases and the need for more randomized controlled trials.
It is interesting that, while the report focused on the potential dangers of high-dose vitamin D, the committee still raised the RDA from 400 to 600 IU daily and the upper safety limit was doubled from 2,000 IU to 4,000 IU daily. I think this is progress in terms of being able to raise people's serum 25(OH)D to sufficient levels. But, I'm a "glass half full" kind of person!
The dose we're using in our (breast cancer risk reduction) trial is 20,000 IU weekly vs. placebo, plus a standard dose given to both groups (now 600IU daily). For the women who are currently enrolled, the study dose is below the current upper safety limit.
Lee Lipsenthal, MD, Founder/Director, Finding Balance in a Medical Life (www.findingbalanceprograms.com); former Medical Director of Dr. Dean Ornish’s Preventive Medicine Research Institute, Sausalito, CA:
Although I am no expert in this area, after reviewing the IOM report, I think it's important to point out that they were specifically addressing vitamin D and bone health. I do agree that some supplementation with vitamin D is useful, and I believe sun exposure is important. Americans, to some degree, have become sun-phobic with the fear of skin cancer. The constant use of heavy layers of sun block is detrimental and unnecessary. I agree with IOM that the jury is still out on vitamin D and other health issues such as cancer. At this point, I think that modest supplementation of 1,000-2,000 IU/day is reasonable and not harmful.
Toni Bark, MD, Founder/Director, Center for Disease Prevention & Reversal, Evanston, IL (www.disease-reversal.com):
I think they're nuts! Almost 100% of patients that I test are very deficient. Studies have shown associations between vitamin D deficiency, respiratory illness and influenza. What could be the committee’s motivation? Who sponsored this review? Do we know?
[Editor’s note: The official sponsors, as listed on the IOM’s website, are: Agricultural Research Service, U.S. Department of Agriculture, Department of Defense, Food and Drug Administration, Health Canada, National Institutes of Health, and Office of Disease Prevention and Health Promotion]
Leo Galland, MD, Founder Foundation for Integrated Medicine (www.mdheal.org), New York, NY; author of Power Healing and The Fat Resistance Diet:
Most of the press and much of the commentary surrounding the IOM report is misleading, especially with regard to vitamin D. To see that, you really have to read the report itself, not just the summary or the IOM's lopsided press release.
The fundamental intent of the IOM report was to reinforce the status quo: to state that there is not an epidemic of vitamin D deficiency and that most North Americans get enough vitamin D presently from a combination of food and supplements. At the same time, the panel acknowledged with some ambivalence that high dose vitamin D supplementation is safe. Not only did they raise the tolerable upper limit from 2,000 to 4,000 IU/day, but in the body of the report appears the statement that even 10,000 IU/day is probably safe. That is the only part of the report that can be considered a "step in the right direction".
They rejected as inconclusive and inconsistent the science indicating that vitamin D improves any aspect of health other than bone strength, or that blood levels greater than 20 ng/ml prevent any illness. And they raised concerns about the results of some studies that show an increase in mortality and cancer rates at levels of 25-OH D in the range of 40 to 100 ng/ml.
I do believe that proponents of high-dose vitamin D need to explain the data indicating an increased risk of pancreatic cancer in people with high-normal levels. I've reviewed the studies and they can't be explained away easily. There is also some inconsistent data that risk of breast and prostate cancer, which declines as vitamin D levels go from 0 to 40, may increase at levels greater than about 70, a reverse J-pattern.
The purpose of the IOM report was to make population-based recommendations. It does provide unintentional support for the use of plasma 25-OH D levels in clinical practice, to determine optimal levels for individual patients with specific needs. We clinicians are responsible for the care of individual patients and we need to consider all the data relevant to each patient.
In women who already have breast cancer, the higher the levels of 25-D, the less the risk of distant metastases, at least up to plasma levels of 70 ng/ml. The optimal level for patients with multiple sclerosis is not known, but may be just as high. The optimal level for someone with sarcoidosis is more likely about 16 ng/ml. Cardiovascular risk decreases progressively as 25-D levels rise to about 43, and then hits a plateau. Individualization of treatment decisions is critical. Unfortunately, the IOM report sheds no light on how to make these decisions. But if read in its entirety, it does establish an official sanction for the use of high-dose supplementation, which is a worthwhile outcome!
An analysis, along with documentation of 4 recent positive randomized clinical trials of high dose vitamin D3 supplementation, appears in my blog at www.pilladvised.com.
James Dillard, MD, DC, private practice New York, NY (www.drdillard.com):
This is a consensus statement, not research. We need to do the interventional studies. Though right now there is little blinded, prospective Vitamin D replacement interventional research, I believe the IOM committee will be proven wrong about their position statement over time.
Cathy Creger Rosenbaum, PharmD: Holistic Clinical Pharmacist, Founder & CEO Rx Integrative Solutions (www.rxintegrativesolutions.com):
Mega-dosing of vitamin D and calcium supplements is for the birds! It is true that as individuals get older, vitamin D levels may decrease because they do not metabolize vitamin D into its active form due to kidney changes or conditions that reduce ability to absorb dietary fat from the digestive tract (e.g, pancreatic enzyme deficiency, Crohn's disease, celiac disease, liver disease, or bariatric surgery). Others do not get enough sunlight to produce vitamin D from their skin.
The IOM revised the RDI for vitamin D, concluding the target blood level of 20-30 ng/ml is needed for bone health. Yet, vitamin D is fat-soluble and can accumulate in the body over time. We have seen this happen with two other fat-soluble vitamins, namely vitamin E (associated with increased risk of stroke in doses higher than 200 IU daily) and vitamin A (associated with increased risk of hip fracture in doses higher than 1,250 IU daily).
I have seen patients prescribed vitamin D in very wide-ranging doses, from 1,000 IU daily up to 50,000 IU weekly to correct low vitamin D blood levels. Toxicity may occur in daily doses of 2,000 IU or greater over time. Symptoms of toxicity are hard to pin on the supplement alone, may go unnoticed, and include nausea, constipation, weakness, and weight loss. It's important to monitor blood levels and adjust or remove supplement dosing accordingly.
My general recommendation is that patients should try to get as much of their RDI for calcium (1,000 – 1,200 mg elemental/day) and vitamin D (600-800 IU/day) from the diet depending on age and gender. Teach your patients to be good label-readers and check all food sources to add up daily intake of both. Provide of list of foods rich in calcium and vitamin D as an educational leaflet to take home after an office visit.
Remind patients that they should consume as much calcium and vitamin D in their foods as possible. Most milk in the US is fortified with 400 IU vitamin D per quart. Other food sources include salmon, tuna, sardines, and mackerel. Fifteen minutes' exposure to UV rays from the sun 2-3 times weekly enable our skin to synthesize vitamin D. Most importantly, patients should include bone-stressing exercise (i.e., weight lifting) in their health regimens to protect wrists, hips, and spine from osteoporosis.
Hywel Davies MD, FACP, FRCP, FACC, consultant cardiologist Guy’s Hospital, London; former Chief of Cardiology, University of Colorado, Denver.
The idea that widespread vitamin D deficiency exists in the world has never had any credibility, and the idea that vigorous supplementation is necessary therefore has to be false. But it has been pushed with great vigor by a group, mostly of non-clinical doctors and epidemiologists.
Vitamin D in synthetic form was introduced into the human food chain in the 1920’s, coincidentally with the beginning of what was called the ‘epidemic’ of coronary heart disease. It had, at that time, been shown to prevent rickets in laboratory animals.
Nowadays it is virtually impossible to buy milk in the US that has not been laced (‘fortified’) with vitamin D. The amounts added, and the content, have been subject to dubious control, and a number of fatalities have occurred due to Vitamin D poisoning from milk. The reason given for milk fortification was the prevention of rickets, the bone disease in children common in post-industrial England, and among Black children in relatively sunless northern US states.
Rickets has not existed in the US except in readily defined groups (cults or ethnic groups that avoid the sun) for nearly a century, yet supplementation with synthetic vitamin D products is advocated for all, including young people living outdoors in sun-bathed states like California. This is palpably absurd!
The mis-labeling of this compound as a vitamin is regrettable, as it gave a potential toxin an aura of undeserved innocence. Vitamin D is not a vitamin, but a steroid, which is, in its most active form, a powerful hormone with receptors widely distributed in the tissues of the body. As with other steroids, excessive consumption has risks. For decades, vitamin D has been used experimentally to create coronary heart disease in animals like the dog and the rat where it is not otherwise possible to simulate the forms of disease seen in man.
In 1936, obstetrician Dr. Wayne Brehm of Columbus, OH, showed the maternal and neonatal toxic effects of Viosterol, a synthetic form of Vitamin D, in his patients. This noteworthy study, unknown and unheralded to this day, deserves a place in the annals of medicine as one of the first randomized prospective clinical trials.
In 1972, Swedish and German researchers published striking pictures of heavy calcification in the arteries of ‘normal’ newborns killed in automobile accidents. Vitamin D supplementation of the mothers’ diet was considered as a cause, and no better reason has since been suggested. From South America in the 1970’s came news of a rapidly fatal calcific disease of naturally grazing animals caused by consuming large quantities of Vitamin D in the leaves of Solanum malacoxylon, a shrub of the potato family. In Europe the same occurred in animals eating vitamin D-rich golden oat grass, Trisetum flavescens.
As a practising cardiologist concerned with the calcification of arteries, especially the coronaries, I have long been deeply skeptical of widespread supplementation of the human diet with Vitamin D. The idea that there is wide deficiency is based on a threshold of 30 ng/ml. This is in fact the average value found in the US (admittedly by dubious measurement techniques), but has served to define half the population as being in need of medical attention and supplementation.
The threshold is largely arbitrary, and ‘deficiency’ has been said to cause cancer, multiple sclerosis, hypertension and atherosclerosis. A key assertion in these arguments is that prevalence is related to latitude –for example, the notion that the further north in the US that you go, the more colorectal cancer you see. Examination of the official cancer statistics shows that this again is untrue, and that much of the other supportive evidence is unacceptable.
Sporadic deficiency does exist and must be treated, but this applies to identifiable groups such as older people in institutions. The relationship of Vitamin D metabolism jointly to atherosclerosis and osteoporosis requires further examination. I have expressed these views and the reasoning behind them in some detail in a small book available from a publisher called Lulu.com. It is entitled “Vitamin D in Disarray.” They will also appear in more extended form in the wider context of coronary heart disease and its causes in a book which is about to be published in England entitled “Medicine sans Statistics.”
Roby Mitchell, MD, aka “Dr. Fitt”, Amarillo, TX:
You always have to be suspicious of "science" that is mitigated by conflict of interest----what I call "sciencology.” Conclusions dispensed by sciencologists have to be tempered such that they are able to keep their jobs. This is the “religious” aspect of medicine that mirrors the insanity of protecting pedophiles in the Catholic Church. It’s a human phenomenon that has to do with self preservation and self-propagation. Sciencologists in the past came to the conclusion that you could safely smoke tobacco, or that you could replace estrogens in women with that from horse urine.
The IOM is overseen by Congress. Congress is heavily subsidized by the pharmaceutical industry. Its not likely that anything useful would ever come from their work. I don't know when this organization was formed, but if I was assessing their effectiveness, I'd track morbidity/mortality records since IOM’s inception to see if there has been a positive or negative change. [Editor’s note: IOM was founded in 1970, under a congressional charter that created the National Academy of Sciences, of which IOM is a subsidiary]
The true science on “vitamone” D and its metabolites is unequivocal to objective observers. Cholecalciferol is a hormone with nuclear receptors in the same super-family as testosterone, estrogens and glucocorticoids. These receptors are in the same sub-family as those for thyroid hormone. When these ligands bind to these nuclear receptors, a conformational change happens that up-regulates gene expression. The epigenetic impact is that homeostasis is controlled by the availability of these DNA orchestrators. As the level of these hormones decline with age (starting around age 26) there is a rheostatic decline in homeostatic integrity---we call it “aging.”
Cholecalciferol is a hormone that works in concert with an orchestra of other hormones. There is no such thing as a "vitamin D." Hormone expression is determined not so much by the presence of hormones as the presence and function of hormone receptors.
Our investigation of prostate cancer, for instance, shows that black males use testosterone more efficiently. So, to try to dispense hormone recommendations in a one-size-fits-all, feed-lot style makes no sense in the first place. Patients have to be looked at individually to assess needs for comprehensive hormone replacement. You won't be able to practice good medicine from an insurance code cook book.
Personally, I take 15,000 IU of vitamone D3 based on lab testing and clinical response.