New Study to Research if Supplements of Vitamin D, Fish Oil Reduce Health Risks
With the volume of Vitamin D testing skyrocketing in clinical laboratories across the nation, leave it to government bureaucrats to work at counter purposes to each other. With one hand, the federal Medicare program is proposing to restrict coverage guidelines and reimbursement for Vitamin D testing to Medicare patients. With another hand, the federally-funded National Institutes of Health (NIH) is funding a large, multi-year study to assess the effect Vitamin D supplements and fish oil have in reducing health risks!
Researchers at Harvard Medical School will investigate whether taking daily dietary supplements of Vitamin D or fish oil reduces the risk of developing cancer, heart disease, and stroke in people with no previous history of such illness. Under a $20 million grant from the National Institutes of Health Institutes, researchers from Harvard Medical School and the Brigham and Women’s Hospital in Boston, Massachusetts, will recruit 20,000 participants for the study nationwide.
Interest in the health benefits of vitamin D has grown as evidenced by the increase in volume of laboratory testing for Vitamin d deficiency. Over the past 36 months, Vitamin D testing volume has doubled twice in most labs as patients and their physicians seek to measure Vitamin D levels in response to new research and press reports about links between Vitamin D deficiency and such ailments as heart disease, stroke, cancer, and other medical conditions.
Despite this high level of interest in Vitamin D, Medicare’s largest carrier has proposed restricting reimbursements to medical laboratories for routine Vitamin D testing. The Dark Report reported that Medicare contractor National Government Services (NGS) said it would cover Vitamin D testing only for patients with chronic kidney disease, osteomalacia, hypercalcemia, and rickets and NGS would deny other testing for Vitamin D. (See “Medicare Carrier Proposes No Pay for Vitamin D Test,” TDR, Feb. 23, 2009.)
While there is increased interest in the benefits of Vitamin D and omega-3 fatty acids, definitive evidence on the health benefits and risks of these supplements is unknown. In the upcoming randomized, double-blind, placebo-controlled clinical trial, researchers will determine whether moderate-to-high doses of Vitamin D (about 2,000 individual units) and fish oil (about 1 gram of omega-3 fatty acids) can prevent heart disease; stroke; and colorectal, breast, prostate, and other cancers. Those eligible for the five-year trial—including women older than 65 and men older than 60 without a prior history of cancer, heart disease, or stroke—will be randomly assigned to take either one or both of the supplements or placebo.
“Vitamin D and omega-3s are two of the most promising nutrients we know of for the prevention of cancer, heart disease, stroke, and many other chronic diseases, but we need large-scale randomized trials to clarify the benefits and risks,” said JoAnn E. Manson, M.D., Chief of Preventive Medicine at Brigham & Women’s Hospital in Boston, who is a co-leader of the study. “What is most exciting is that these low-cost supplements have the potential of tremendously reducing the burden of chronic disease in this country and throughout the world if they are shown to be effective.” Manson will work with Julie Buring, Sc.D., an epidemiologist in the hospital’s Division of Preventive Medicine, to co-direct the study.
In addition, the researchers will study the effects of Vitamin D deficiency on patients of African descent. The Boston Globe reported that these patients will comprise one quarter of the participants. Researchers believe people with dark skin are unable to make much Vitamin D from sunlight, a factor that may explain why African-Americans have higher rates of cancer, stroke, and heart disease, the Globe reported. African-Americans also have a higher risk and greater incidence of diabetes and hypertension.
Clinical laboratory managers and pathologists have a right to be frustrated at the mixed messages being sent by different agencies of the federal government. Before the results of this large, federally-funding study will be known, its Medicare carriers are taking steps to restrict access to routine Vitamin D testing by Medicare beneficiaries. Once again, the nation’s medical laboratories are caught in the middle between how physicians practice medicine—and order laboratory tests—and government restrictions on how laboratories can submit claims and be paid for these tests.
SIPA 2009 - Best Investigative Reporting - Editorial Award
Related Articles:
Largest Study of Vitamin D and Omega-3s Set to Begin Soon at Brigham and Women’s Hospital
Big U.S. Study will Test Vitamin D, Fish Oil
Brigham Study to Test Vitamin D, Fish Oil Supplements
Medicare Carrier Proposes No Pay for Vitamin D Test, The Dark Report
The ideal serum concentration of activated Vitamin D3 is at least 50ng/ml. Get some beneficial rays from the sun and find a new doctor who understands the critical importance of Vitamin D. And supplement if you do not feel comfortable with direct sun- even though this is the natural way to go.
Vitamin D deficiency is America’s #1 health crisis by a wide margin. It is directly liked to most cancers, all of heart didease, diabetes, MS, Mac Degen, depression, shcizophrenia, dementia,muscle weakness, and autism- just to mention a few.
Generally speaking it takes 1000iu/daily/D3 to raise vitamin d status 10ng/ml 25nmol/l.
However, for people with an inflammatory condition, such as celiac disease, it may take twice that amount.
We know for certain that people with a 25(OH)D status below 50nmol/l 20ng/ml have double the death rate compared to people with a 25(OH)D above 100nmol/l 40ng/ml. So raising status above 50ng 125nmol/l will lower inflammatory status an improve life expectancy.
Rather than being a mixed message, I think their actions are very consistent. Most payers, public and private, are using the lack of evidence for a practice as a good reason to put the brakes on fads that are, in many cases, driven by businesses who derive profits from those fads. It is not surprising that payers are seeking to slow down the expense growth you described, but given the interest by the public, I can also understand their interest in developing an evidence-base to drive future policy. This is one more example of where laboratories need to get engaged in the development of best practices and comparative effectiveness studies. It may be the single most important thing we can do to reach alignment with payers on the importance of appropriate reimbursement for laboratory services.
…. And then there is the study published in the December 2008 issue of Military Medicine showing that veteerans with a vitamin D deficiency requird $3,262 more medical care annually than non-deficient veterans. Deficiency was defined as a 25(OH)D level less than 20 ng/ml. 40.5% of the group were deficient. Attaining vitamin D sufficiency in the population is a potential financial disaster for those who profit from disease.
To Paul Epner
The link between cancer rates and vitamin D deficiency was first proposed in 1980 by Garland. Since that time, 60 epidemiology studies have supported the hypothesis, a double blind placebo study confirmed up to a 77% reduction in cancer incidence for those on vitamin D supplements and two years ago the Canadian Cancer Society started recommended that everyone take vitamin D to prevent cancer. Experts on vitamin D will tell you the extent of the data on vitamin D preventing cancer is now as extensive as the data on smoking causing cancer. Correcting vitamin D deficiency is now so well accepted it is almost part of standard medical care. If your primary care physician does not check you levels it’s time to get a new doctor! At this late stage, NIH wants to start a placebo controlled study to prove that correcting a deficiency is good for you. (We are all deficient thanks to that other great piece of advice to stay out of the sun at all costs) Even worse, the study will probably come out negative because who in their right mind would stay on placebo for years and deliberately remain deficient. Someone missed the boat on this one!!!
It appears that a daily 2,000 IU vitamin D supplement will be given (which is good) but I can’t find any information regarding whether or not the blood level of vitamin D (25-OH-D) will be (a) measured at the start to establish a baseline; (b) at regular intervals during the 5 year study; and, (c) at the end of the study. Without this “dose/response” information, this expensive study will (IMHO) be a waste of time and money.
It seems to me that the study should establish “target” levels of 25-OH-D (i.e., 50, 100, 150 and 200 nmol/L) and then adjust the dose to attain/sustain those levels.
In addition, there doesn’t seem to be any interest in looking at whether or not UVR-induced vitamin D is superior, inferior or the same as supplement-induced.
But then, given the fact that the IOM vitamin D committee failed to include any of the acknowledged vitamin D experts, why should the limitations of this study be surprising.
I have measured many D levels before and after supplementing with 1-2000 IU of OTC a day and find extremely variable results.
Even in the most compliant of patients some have had DROPS in the levels even though they take it. FDA dose not regulate how much D3 is actually in the caps so buyer and doctor beware!
I think following serum levels is the best way to go. Most patients need a prescription if the are below 20 for example.
In reply to Dr. Savin; D3 bottles do label the IU/capsule. Perscription D is unfortunately D2 (unless changed w/i the past yr). D2 is the “unnatural” form which is less bioaviable. I have seen D3 capsules as high as 10,000 IU.
As for varying results, that occurs with prescription & non-perscription drugs. I am assuming my particular brand of D3 labels the dosage honestly.