Micronutrients and Child Health Study
- Conditions
- Malaria
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 612
- 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
- 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
- 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 Anthropometric indices 57 weeks after start of intervention Plasma immunoglobulin concentrations 2 weeks after malaria episodes
Trial Locations
- Locations (1)
Kilimanjaro Christian Medical Centre
🇹🇿Moshi, Tanzania
Kilimanjaro Christian Medical Centre🇹🇿Moshi, Tanzania