NCT00421668

A Trial of Zinc and Micronutrients in Tanzanian Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,400 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 6 Weeks – 18 Months
• Healthy volunteers: Accepted

Summary

A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.

Detailed description

We propose to study the efficacy of zinc or multiple micronutrient supplementation in reducing the risk of infectious diseases and growth faltering among infants and young children in Tanzania. Infants born to HIV-negative women will be recruited and randomly assigned in a factorial design to either zinc, micronutrients (vitamins C, E, B1, B2, niacin, B6, folate and B12), micronutrients plus zinc, or a placebo given daily. Children will be followed at monthly clinic visits from age 6 weeks for 18 months. Data obtained will include socioeconomic status, anthropometric data (weight, length, head circumference, and arm anthropometrics), dietary intake (including breastfeeding duration and frequency), hemoglobin, ferritin, and blood smear for malaria. The primary outcomes will be the incidence of diarrhea and respiratory tract infections. Secondary outcomes will be weight and length gain. A subset of children will be tested for blood concentrations of vitamin A, E, zinc and C-reactive protein. All children will receive a large periodic dose of vitamin A every 6 months as per standard of care in Tanzania.

Conditions

• Diarrheal Illnesses
• Respiratory Illness
• Growth Faltering

Interventions

Type	Name	Description
DRUG	Zinc	zinc
DRUG	Multivitamins	Vitamins C, E, B1, B2, niacin, B6, folate and B12
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2007-01-12
• Last updated: 2017-03-03

Locations

1 site across 1 country: Tanzania