A new study aimed at determining if Vitamin D and fish oil supplements can prevent cardiovascular disease might be jeopardizing the health of the research participants who are receiving the placebo pills, evidence suggests.
In the story documented on Medscape, a 57-year-old patient who recently visited her doctor found out that her Vitamin D levels were low. The doctor prescribed a Vitamin D supplement to address the issue, but the patient informed her physician that she was currently in a study that asked participants to refrain from taking supplements as they could affect the integrity of the ongoing research. Her doctor believes the woman was in the control group in the study, and therefore she was receiving a placebo.
Dr. JoAnn Manson, an organizer of the Vitamin D study, said testing a participant’s Vitamins D levels “wouldn’t necessarily reveal to the participants whether they’re in the placebo group or active treatment group. It is true that if their blood is tested and it turns out that they’re deficient that it’s more likely they’re in the placebo group than the active treatment group, but it does not appear to be happening often.”
Many doctors believe these types of studies can put a patient in danger, but the team of researchers leading the Vitamin D study said they have taken steps to alleviate risk.
“We keep [the participants] really well informed about what the research is showing and that these questions are still unanswered — still inconclusive — and that the trial is still critically important to answering these clinical and public health questions,” said Manson.
Prevalence of Out-Of-Study Medication
One of the main difficulties researchers face during long-term studies is ensuring participants adhere to the set guidelines. Most studies ask participants to take an active role in the research, and oftentimes this involves regular exercise, or adherence to a dietary and supplementation guidelines. Manson said out-of-study medication is “a very real concern” for researchers, as it could limit the accuracy of the clinical trials. Despite the concern, data suggests than fewer than 5 percent of individuals take high-dose supplementation outside of research protocol.
While out-of-study supplementation may not be too grave of an issue, Dr. Silverman believes studies like the above trial can negatively affect a person’s health.
“I actually met a patient who was in this study, and I left the encounter with conflicted feelings.
My patient’s Vitamin D levels were significantly below normal, and she required supplementation before I could safely consider surgery. She was hesitant, as she had been instructed not to take any supplemental Vitamin D.
The conflict of interest occurs in this study when we know that certain levels of Vitamin D are below those for normal health, and preventing patients from achieving a normal healthy level seems troublesome. Some of these patients were given placebo pills instead of true Vitamin D. Examining their long-term cardiovascular risks by putting their bone health and other metabolic systems at risk from a lack of normal Vitamin D doesn’t seem like a truly well-done study. I wonder how they got this past their Institutional Review Board?
It’s one thing to do a study demonstrating a difference between healthy and other forms of treatment, but to do a study that puts people in the control group at risk, especially when we already know the dangers of Vitamin D deficiency, bothers me to the core.”
Related source: Medscape