A Trial of Zinc and Micronutrients in Tanzanian Children

Phase 3

Completed

• Conditions: Diarrheal Illnesses; Respiratory Illness; Growth Faltering
• Interventions: Drug: Multivitamins; Drug: Placebo; Drug: Zinc

• Registration Number: NCT00421668
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief 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.

Study Timeline

• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-12
• Study Start: 2007-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• Singleton, live born infants born to HIV- negative women
• Mothers will need to have registered for pre-natal care before 34 weeks gestation
• intend to stay in Dar es Salaam for until delivery and 18 months thereafter.

Exclusion Criteria

• infants born with multiple congenital abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Multivitamins	Multivitamins	Vitamins C, E, B1, B2, niacin, B6, folate, and B12
Multivitamins + Zinc	Multivitamins	Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc
Placebo	Placebo	placebo
Multivitamins + Zinc	Zinc	Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc
Zinc	Zinc	zinc

Primary Outcome Measures

Name	Time	Method
Incidence of diarrhea	from ages 6 weeks to 18 months
respiratory tract infections	from ages 6 weeks to 18 months

Secondary Outcome Measures

Name	Time	Method
Weight gain	from age 6 weeks to 18 months
Length/height gain	from age 6 weeks to 18 months

Trial Locations

Locations (1)

Muhimbili Uinverstiy College of Health Sciences; 🇹🇿 Dar es Salaam, Tanzania