1,188
Participants
Start Date
September 5, 2017
Primary Completion Date
February 28, 2020
Study Completion Date
March 26, 2020
Azithromycin Oral Liquid Product
Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months
Nitazoxanide Oral Suspension
Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months
Nicotinamide
"Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.~Children in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age"
Placebos
"Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.~Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.~Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age"
Haydom Lutheran Hospital, Haydom
University of Virginia
OTHER
Bill and Melinda Gates Foundation
OTHER
Haydom Lutheran Hospital
OTHER