A Trial of Zinc and Micronutrients in Tanzanian Children

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Completed

CT.gov ID

NCT00421668

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

2,400

Enrollment

Location

Arms

Duration (Months)

39.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diarrheal Illnesses Respiratory Illness Growth Faltering	Drug: Zinc Drug: Multivitamins Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

2400 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Trial of Zinc and Micronutrients in Tanzanian Children

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multivitamins Vitamins C, E, B1, B2, niacin, B6, folate, and B12	Drug: Multivitamins Vitamins C, E, B1, B2, niacin, B6, folate and B12
Experimental: Multivitamins + Zinc Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc	Drug: Zinc zinc Drug: Multivitamins Vitamins C, E, B1, B2, niacin, B6, folate and B12
Experimental: Zinc zinc	Drug: Zinc zinc
Placebo Comparator: Placebo placebo	Drug: Placebo Placebo

Outcome Measures

Primary Outcome Measures

Incidence of diarrhea [from ages 6 weeks to 18 months]
respiratory tract infections [from ages 6 weeks to 18 months]

Secondary Outcome Measures

Weight gain [from age 6 weeks to 18 months]
Length/height gain [from age 6 weeks to 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.