Micronutrients and Child Health Study (MACH)

Wageningen University

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamins and minerals other than zinc; Dietary Supplement: Zinc; Dietary Supplement: Vitamins plus zinc and other minerals

Study type: Interventional

Funder types: Other

Identifiers

NCT00623857

WAO 93-442

Details and patient eligibility

About

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.

Full 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.

Enrollment: 612 patients

Sex: All

Ages: 6 to 60 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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612 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Zinc

Treatment:

Dietary Supplement: Zinc

2

Active Comparator group

Description:

Vitamins and minerals other than zinc

Treatment:

Dietary Supplement: Vitamins and minerals other than zinc

3

Active Comparator group

Description:

Vitamins plus zinc and other minerals

Treatment:

Dietary Supplement: Vitamins plus zinc and other minerals

4

Placebo Comparator group

Description:

Placebo for all vitamins and minerals

Treatment:

Dietary Supplement: Placebo