Malaria
Conditions
Keywords
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
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.
Interventions
DIETARY_SUPPLEMENTZinc
Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
DIETARY_SUPPLEMENTVitamins and minerals other than zinc
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
DIETARY_SUPPLEMENTVitamins plus zinc and other minerals
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
DIETARY_SUPPLEMENTPlacebo
Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks
Sponsors
Kilimanjaro Christian Medical Centre, Tanzania
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Febrile malaria episodes | 60 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Haematologic and urinary indicators of micronutrient status | 30 weeks after start of intervention |
| Anthropometric indices | 57 weeks after start of intervention |
Countries
Tanzania
Outcome results
None listed