Location: Obesity and Metabolism Research
Project Number: 2032-51000-004-42-R
Project Type: Reimbursable Cooperative Agreement
Start Date: Jan 1, 2018
End Date: Mar 31, 2020
The study is testing the efficacy of relatively simple targeted interventions including antimicrobials to address infections and niacin in the form of nicotinamide to address infection-related inflammation and improve the intestinal microbiota of infants.
The University of Virginia (UVA) is responsible for study implementation in Tanzania, intervention procedures and data and sample collection, storage and shipping. The 4-arm intervention design includes a control, niacin, antimicrobials, and niacin + antimicrobials treatment groups for the infants, and niacin and control groups for the mothers. Targeted interventions for the tryptophan-niacin pathway are as follows: Mothers: daily supplementation with nicotinamide (250mg) from delivery through 6 months postpartum; Infants: daily nicotinamide (100mg) from 6 through 18 months of age. The microbials Intervention is only applied to the infants: azithromycin 20mg/kg at 6, 9, 12, and 15 months; and nitazoxanide 100mg twice daily at 12 and 15 months. Human milk samples are collected at two time points. ARS-Western Human Nutrition Center is responsible for breast milk analyses for nicotinamide and other B-vitamins (2 x 1200 samples), additional niacin vitamers (2 x 600 samples),and free and total tryptophan (2 x 600 samples).