The use of a placebo in a study assessing whether vitamin D supplements reduced the number of asthma attacks in kids with asthma raised some eyebrows in research ethics circles, according to a recent online publication in Science.
Per the article, children with asthma and known to have low vitamin D levels were to receive either a high-dose vitamin D supplement or a placebo with no vitamin D at all. Because children with asthma may be routinely treated with corticosteroids, they may have faced increased risks to bone health at baseline. An untreated vitamin D deficiency may increase their risk for fractures. For that reason, similar studies have used a lower vitamin D does rather than a placebo for the control group.
Other ethical concerns raised in the article are that the study focused on minority children, and whether the consent form adequately described some risks.
In response to the concerns mentioned in the Science article, a study researcher pointed out that the federally funded study was reviewed before and after it was funded, including by a Data Safety and Monitoring Board and IRBs at seven pediatric hospitals.