Micronutrients and Child Health Study

Study Overview
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Brief Summary
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The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.

Detailed Description
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Zinc is essential for the functioning of the immune system. Supplementation trials in Asia, Latin America, the Pacific and developed countries have shown that increasing zinc intake has great potential to control common infections in children, but the response to supplementation may be different in Africa, where the primary environmental challenge to children's health is malaria. Simultaneous supplementation with other potentially limiting nutrients may be required to overcome a lack of response when zinc is given alone. The project aims at measuring effects of daily oral supplementation with zinc and other micronutrients, given either alone or in combination, on malaria incidence and nutritional status, and on indicators of immunity.

Official Title
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Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children

Conditions
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Malaria

Intervention / Treatment
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* Dietary Supplement: Zinc
* Dietary Supplement: Vitamins and minerals other than zinc
* Dietary Supplement: Vitamins plus zinc and other minerals
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 6-60 months Permanently residing in the study area Being moderately or mildly stunted (height-for-age z-score <-1.5 SD) Informed consent from parents or guardians obtained Exclusion Criteria: Severe wasting (weight-for-height z-score <-3 SD) Hemoglobin concentration <70 g/L Axillary temperature ≥37.50 °C with malaria antigenemia Signs and symptoms at randomisation suggesting malaria, hepatitis, HIV/AIDS, tuberculosis, sickle cell disease or other severe condition Unable to produce a venous blood sample (>1 mL)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Zinc | Dietary Supplement: Zinc<br>* Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks<br>|
| Active Comparator: 2<br>Vitamins and minerals other than zinc | Dietary Supplement: Vitamins and minerals other than zinc<br>* Daily supplementation with vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks<br>|
| Active Comparator: 3<br>Vitamins plus zinc and other minerals | Dietary Supplement: Vitamins plus zinc and other minerals<br>* Daily oral supplementation with zinc, vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks<br>|
| Placebo Comparator: 4<br>Placebo for all vitamins and minerals | Dietary Supplement: Placebo<br>* Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile malaria episodes |  | 60 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haematologic and urinary indicators of micronutrient status |  | 30 weeks after start of intervention | 
| Anthropometric indices |  | 57 weeks after start of intervention | 
| T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate |  | 30 weeks after start of intervention | 
| Plasma immunoglobulin concentrations |  | 2 weeks after malaria episodes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micronutrients, Zinc, Vitamins, Trace elements, Minerals, Vitamin A, Vitamin B1, Vitamin B2, Niacin, Vitamin B6, Folic acid, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Iron, Iodine, Copper, Selenium, Magnesium, Calcium, Malaria, Immunity, Anthropometry