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Complaint that Pitt kids' study on vitamin D and asthma is 'unethical' leads to changes

Sean D. Hamill, Pittsburgh Post-Gazette on

Published in Health & Fitness

"The research is public, and publicly funded, and the hospitals advertise it on their web sites and they say, 'Call us if you have questions,'" he said. "I imagine (they won't answer questions because) they're embarrassed about it."

Davidson's attention was drawn to Celedon's study this summer because he and several colleagues in Qatar earlier this year finished the analysis of their own study -- published in the journal Chest in September -- examining the effects of vitamin D on children with asthma who had low levels of vitamin D.

But in their study -- which looked at whether an initial, very high dose of vitamin D was better than daily supplementation -- they decided it was not acceptable to use a no-dose placebo.

"Since the American Academy of Pediatrics had recommended a minimum daily intake of 400 International Units, we did not consider a nonsupplemental (placebo) control group appropriate," he and his colleagues wrote in the journal article.

Research into the effects that healthy levels of vitamin D have on a variety of chronic diseases -- not just asthma, but cancer, heart disease, multiple sclerosis, the common cold and others -- has been a hot topic for much of the last decade.

The working theory is that vitamin D helps with asthma and other conditions by boosting the immune system, helping the body fight back. Persistently low levels of vitamin D in kids can rarely result in rickets, a softening of the bones, but can lead to other health issues.

Multiple studies in recent years have examined whether vitamin D helps reduce asthma attacks in adults and children. None of them, however, focused solely on participants with low levels of vitamin D like Celedon is now doing -- which is a big reason why even those researchers who object to giving a no-dose placebo to kids would like there to be changes made so his study can go forward.

"I think it's a particularly important trial because kids are underrepresented in clinical trials on this," said Adrian Martineau, a professor of respiratory disease and infection at Queen Mary University of London, and lead author on a journal article last year that looked at all the major published studies involving vitamin D and asthma.

Many of the results of previous studies show that boosting vitamin D tends to help those who have low levels of vitamin D the most.

But Alan Fleischman, a bioethicist and professor of pediatrics at the Albert Einstein College of Medicine in New York, said 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."

That may be OK under the regulations, Davidson said, but particularly when it comes to doing research involving children "you're never supposed to abandon the standard of care."

Doing otherwise, he said, "is taking advantage of kids."

(c)2017 Pittsburgh Post-Gazette

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