January 20, 2022

Vitamin D clinical trial for kids may be unethical

Could be a manifestation of structural racism

A University of Pittsburgh clinical trial on the effects of Vitamin D on children with asthma has come under attack for being unethical.

The Vit-D-Kids trial of a proposed 400 children was meant to study whether very high doses of Vitamin D could help those with severe asthma. The children in a control group received only a placebo and no Vitamin D; the children in the other group received the high dose.

Bruce Davidson, a pulmonary and critical-care researcher in Seattle who helped perform a similar study with children in Qatar, believed that it was unethical to give no Vitamin D to children, who were often minority children living in poor neighbourhoods. The researchers, he said, should have compared maintenance levels of Vitamin D with high levels.

But Alan Fleischman, a bioethicist at the Albert Einstein College of Medicine in New York, told the Pittsburgh Post-Gazette a couple of years ago that even though giving kids known to have low levels of vitamin D a supplement would help them, it is not unethical under federal regulations to give them a no-dose placebo. “A placebo trial is ethical when children aren’t being asked to give up something,” he said. Giving them a placebo “does not increase risk to children who don’t get an active drug.”

The controversy has not gone away although the trial has already been cancelled. Science magazine has published a long article which uncovered new angles on the ethical questions.

“The advantages to society of this trial, because of the poor design, were likely none. And the risks did outweigh the benefits,” Charles Natanson, a physician and expert on trial design at the NIH Clinical Center told Science. “This trial did not, in my opinion, meet the standards set forth in The Belmont Report” (a 1979 study which set standards for human subject research).

Jill Fisher of the University of North Carolina, Chapel Hill, complained that the trial represented “structural racism” because minority children were already at risk of Vitamin D deficiency. “We shouldn’t say, ‘It’s unfortunate that there are these health and nutritional disparities, but it serves the interests of science to have placebo-controlled trials,’” she told Science.

The central issue in the controversy is “usual care”. It:

exemplifies the growing number of studies in humans that inappropriately reject control groups receiving “usual care”—current best practice treatments used by doctors. In a hunt for compelling results, many researchers favor using sharply divergent treatment arms in a trial. But such extreme comparisons mean doctors can’t learn whether a new treatment is better or worse than usual care,

“It’s just common sense,” says Charles Natanson, a physician and expert on trial design at the NIH Clinical Center. “Why study two things inside of a trial that nobody does outside of the trial?”

Michael Cook is editor of BioEdge

Creative commons
clinical trials