Friday, April 13, 2018 by Isabelle Z.
In case you needed any more proof of how essential vitamin D is to good health, researchers have warned that placebo-controlled trials that involve limiting some people’s intake of the all-star nutrient could be considered unethical.
This presents a serious quandary for researchers. Demonstrating the efficacy of vitamin D in studies is essential for boosting awareness and acceptance of its treatment effects, but the very design of many studies could cause some patients to miss out on the vitamins they need.
Writing in the journal Nutrients, George Washington University School of Medicine and Health Sciences Integrative Medicine Program Director Dr. Leigh Frame outlined just what could happen if a person known to be deficient in vitamin D was denied it. The potential problems include poor short-term or long-term bone health and a higher risk of chronic disease, cancer, autoimmunity, infection and mental illness.
The researchers involved in the review cited two types of trial design as having potentially conflicting objectives. The first is studies with an active control arm with no placebo group. In this case, they point out that the benefit of such a study could be dampened if the absence of a placebo causes them to get non-significant results. Having an active control could limit the possibility of detecting meaningful effects from the supplement.
In the case of placebo trials, valuable information is often gleaned but the ethical questions could be a deal-breaker. Because vitamin D deficiency is a “known harm” and vitamin D has known benefits, they believe that withholding adequate supplementation from some people in the study could cause them an undue health risk. They believe the potential benefits that can be gained by determining an ideal dose of vitamin D would not necessarily outweigh the harm that could be caused to those who are deprived of supplementation.
They’ve identified two possible solutions to these problems. First, they suggest designing trials that have placebo groups but without supplement restrictions. For example, a study called the Vitamin D and Omega 3 Trial allowed participants to take up to 400 IU per day, which is the recommended daily allowance. The researchers in that study then monitored the vitamin D levels of people in both groups; the control group was effective despite having slightly higher background levels of vitamin D.
Another solution they put forth entails having a placebo group but then giving them a rescue repletion program at the close of the study. Those in the placebo group might have a vitamin D deficiency during the study, but they’d be given doses afterward that could reduce their risk of harm. They say this would not only protect the methodology but would also stay in line with the ethical placebo group guidelines set out by the 2001 Declaration of Helsinki.
Vitamin D continues to be the subject of trials and studies as more and more information comes to light regarding what a powerful tool it is for optimum health. For example, one recent study found that vitamin D has the potential to cut a person’s risk of cancer by 20 percent or even more.
In addition, it plays a vital role in bone health, helping your body absorb much-needed minerals like phosphorus and calcium and reducing your risk of fractures. It also helps reduce your risk of both types of diabetes, and those with sufficient vitamin D intake also have a lower risk of heart disease.
Daily exposure to natural sunlight without sunscreen is the best way to boost your vitamin D levels, but supplementation is a good route when this isn’t possible. Follow more news on Vitamin D at VitaminD.news.
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