Micronutrients and Child Health Study

Wageningen University612 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

612

Conditions

Malaria

Interventions

ZincDIETARY_SUPPLEMENT

Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks

Vitamins and minerals other than zincDIETARY_SUPPLEMENT

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

Vitamins plus zinc and other mineralsDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 60 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Outcomes

Primary Outcomes

Febrile malaria episodes

Time frame: 60 weeks

Secondary Outcomes

Haematologic and urinary indicators of micronutrient status

Time frame: 30 weeks after start of intervention

Anthropometric indices

Time frame: 57 weeks after start of intervention

T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate

Time frame: 30 weeks after start of intervention

Plasma immunoglobulin concentrations

Time frame: 2 weeks after malaria episodes

Data from ClinicalTrials.gov

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