Emily
Editor, Senior Moderator
https://science.sciencemag.org/content/373/6556/729
Failure to protect?
By Charles Piller
Science13 Aug 2021 : 729-733
A study of asthmatic children, most of them Black, shows how a common clinical trial design can expose vulnerable participants to serious risks.
Juan Celedón, a respected pulmonary researcher at the University of Pittsburgh, wanted to address an urgent national problem. Severe asthma attacks send hundreds of thousands of U.S. children to the hospital every year. For decades, researchers have suspected extra vitamin D—essential for bone growth and healthy development, and also an immune modulator in children and adults—might help them. In 2016, Celedón and colleagues launched a major trial to test that premise.
With $4.3 million in funding from the National Heart, Lung, and Blood Institute (NHLBI) and support from a vitamin company and a drug firm, they enrolled asthmatic kids who had low or deficient levels of vitamin D—many from urban, minority communities; most were Black. Half of the 400 planned participants would receive a daily high-dose vitamin D supplement for about 1 year. The other half would serve as controls. The researchers also made a decision that cast a shadow over the trial—and inflamed a controversy confronting many other trials of similar design. Instead of treating the randomly chosen control group with a more modest dose of vitamin D—as many medical authorities advise for children with a deficiency of the vitamin—the researchers chose to give them a placebo.
When Seattle physician Bruce Davidson, a pulmonary specialist who has studied vitamin D and asthma, heard about the “Vit-D-Kids” trial, he was stunned...
Failure to protect?
By Charles Piller
Science13 Aug 2021 : 729-733
A study of asthmatic children, most of them Black, shows how a common clinical trial design can expose vulnerable participants to serious risks.
Juan Celedón, a respected pulmonary researcher at the University of Pittsburgh, wanted to address an urgent national problem. Severe asthma attacks send hundreds of thousands of U.S. children to the hospital every year. For decades, researchers have suspected extra vitamin D—essential for bone growth and healthy development, and also an immune modulator in children and adults—might help them. In 2016, Celedón and colleagues launched a major trial to test that premise.
With $4.3 million in funding from the National Heart, Lung, and Blood Institute (NHLBI) and support from a vitamin company and a drug firm, they enrolled asthmatic kids who had low or deficient levels of vitamin D—many from urban, minority communities; most were Black. Half of the 400 planned participants would receive a daily high-dose vitamin D supplement for about 1 year. The other half would serve as controls. The researchers also made a decision that cast a shadow over the trial—and inflamed a controversy confronting many other trials of similar design. Instead of treating the randomly chosen control group with a more modest dose of vitamin D—as many medical authorities advise for children with a deficiency of the vitamin—the researchers chose to give them a placebo.
When Seattle physician Bruce Davidson, a pulmonary specialist who has studied vitamin D and asthma, heard about the “Vit-D-Kids” trial, he was stunned...