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.