Early Life Interventions for Childhood Growth and Development In Tanzania

• Status: Completed
• Trial end date: 2020-03-26
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haydom Lutheran Hospital
• Collaborators: Bill and Melinda Gates Foundation; University of Virginia
• Treatments: Azithromycin; Niacin; Niacinamide; Nicotinic Acids; Nitazoxanide

Criteria

Inclusion Criteria:

1. Maternal age ≥18

2. Infant ≤ 14 days

Exclusion Criteria:

1. Maternal inability to adhere to protocol

2. Multiple gestation

3. Severe illness (significant birth defect, hospitalization, severe neonatal illness)

4. Birth weight <1500 g

5. Lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment).