Micronutrients and Child Health Study

Phase 3

Completed

• Conditions: Malaria
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Zinc; Dietary Supplement: Vitamins and minerals other than zinc; Dietary Supplement: Vitamins plus zinc and other minerals

• Registration Number: NCT00623857
• Lead Sponsor: Wageningen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-26
• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 612

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
4	Placebo	Placebo for all vitamins and minerals
1	Zinc	Zinc
2	Vitamins and minerals other than zinc	Vitamins and minerals other than zinc
3	Vitamins plus zinc and other minerals	Vitamins plus zinc and other minerals

Primary Outcome Measures

Name	Time	Method
Febrile malaria episodes	60 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Tanzania