PITTSBURGH--A federally funded, University of Pittsburgh research project, testing whether children with asthma attacks benefit from high doses of vitamin D, will be altered following complaints from an outside researcher to federal officials that the study was "unethical."
Bruce Davidson, a pulmonary and critical care researcher in Seattle who helped perform a similar study with children in Qatar, was bothered that the study run by Pitt out of Children's Hospital of Pittsburgh of UPMC and three other U.S. sites was proposing to give half of the 400 participants who already have low vitamin D levels, a placebo with no vitamin D for a year.
"It is unethical to treat children known to be deficient in vitamin D with placebo," Davidson wrote in a letter in August to the National Heart, Lung and Blood Institute, a division of the National Institutes of Health. The NIH is providing $2.3 million in funding over three years and is overseeing the study, which is still recruiting participants 6 to 13 years-old and has not yet begun.
In conversations with nine experts on bioethics, vitamin D, bone health and asthma -- none of whom were involved in the study -- the Pittsburgh Post-Gazette found that not all of them agree with Davidson that using a no-dose placebo is unethical.
By using a no-dose placebo and comparing it to a high dose of 4,000 international units a day, the study's results "hopefully will be black and white" about what works and what doesn't, said Michael Holick, an expert on vitamin D and its effects on humans. "Whereas, if you gave the (control group) kids 600 units (a day) the answers would be gray."
But some prominent experts do agree with Davidson, arguing that all of the participants should at least be given a maintenance dose of vitamin D to ensure their health and development.
"If I was on an (Institutional Review Board that needs to approve such studies at Pitt) I would have recommended that the control group get a maintenance dose" instead of a placebo, Neville Golden, a professor of pediatrics at Stanford University and an expert on bone health in children, said in an interview. "They could definitely get a valuable result" without using a no-dose placebo.
With experts divided, Davidson's concern was enough that the NHLBI convened its Data Safety Monitoring Board and investigated the issues he brought up, which included that the study would likely involve a significant percentage -- if not a majority -- of minority children. Blacks are more likely to have asthma for a variety of reasons, and low levels of vitamin D than white children because their darker skin makes it harder to produce vitamin D from the sun.
"When issues are raised, we take them very, very seriously," James Kiley, director of the NHLBI's division of Lung Diseases, where the study is overseen, said in an interview. "There are a number of things that will be done as a result of Dr. Davidson's concerns."
"We want to make sure that all the trials are safe and ethical," Kiley said.