A Trial of Zinc and Micronutrients in Tanzanian Children

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: Growth Faltering; Diarrheal Illnesses; Respiratory Illness

Treatments: Drug: Zinc; Drug: Multivitamins; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00421668

HD048969

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,400 patients

Sex: All

Ages: 6 weeks to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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2,400 participants in 4 patient groups, including a placebo group

Multivitamins

Experimental group

Description:

Vitamins C, E, B1, B2, niacin, B6, folate, and B12

Treatment:

Drug: Multivitamins

Multivitamins + Zinc

Experimental group

Description:

Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc

Treatment:

Drug: Zinc

Drug: Multivitamins

Zinc

Experimental group

Description:

zinc

Treatment:

Drug: Zinc

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo