A Trial of Zinc and Micronutrients in Tanzanian Children

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

Detailed Description
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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.

Official Title
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A Trial of Zinc and Micronutrients in Tanzanian Children

Conditions
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Diarrheal Illnesses, Respiratory Illness, Growth Faltering

Intervention / Treatment
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* Drug: Zinc
* Drug: Multivitamins
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivitamins<br>Vitamins C, E, B1, B2, niacin, B6, folate, and B12 | Drug: Multivitamins<br>* Vitamins C, E, B1, B2, niacin, B6, folate and B12<br>|
| Experimental: Multivitamins + Zinc<br>Vitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc | Drug: Zinc<br>* zinc<br>Drug: Multivitamins<br>* Vitamins C, E, B1, B2, niacin, B6, folate and B12<br>|
| Experimental: Zinc<br>zinc | Drug: Zinc<br>* zinc<br>|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diarrhea |  | from ages 6 weeks to 18 months | 
| respiratory tract infections |  | from ages 6 weeks to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | from age 6 weeks to 18 months | 
| Length/height gain |  | from age 6 weeks to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Tanzania, Micronutrients, Infants/children, Infectious Disease, Growth faltering