Location: Obesity and Metabolism Research
Project Number: 2032-51530-025-038-R
Project Type: Reimbursable Cooperative Agreement
Start Date: Jan 1, 2018
End Date: Sep 30, 2021
Objective:
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.
Approach:
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).
