Official Title: “Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study

Study Primary Completion Date: June 2009

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Zinc
  • Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
• Dietary Supplement: Vitamins 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 Supplement: Vitamins 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 Supplement: Placebo
  • Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Zinc
• Active Comparator: 2
  • Vitamins and minerals other than zinc
• Active Comparator: 3
  • Vitamins plus zinc and other minerals
• Placebo Comparator: 4
  • Placebo for all vitamins and minerals

Primary Measures

• Febrile malaria episodes
  • Time Frame: 60 weeks
    Safety Issue?: No

Secondary Measures

• Haematologic and urinary indicators of micronutrient status
  • Time Frame: 30 weeks after start of intervention
    Safety Issue?: Yes
• Anthropometric indices
  • Time Frame: 57 weeks after start of intervention
    Safety Issue?: No
• T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate
  • Time Frame: 30 weeks after start of intervention
    Safety Issue?: No
• Plasma immunoglobulin concentrations
  • Time Frame: 2 weeks after malaria episodes
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 60 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wageningen University

Overall Clinical Trial Officials and Contacts

Hans Verhoef, PhD Principal Investigator Wageningen University, Cell Biology and Immunology Group  

Overall Contact: Hans Verhoef, PhD + 255 787 882596 hans.verhoef@wur.nl

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00623857

Study ID Number: WAO 93-442

ClinicalTrials.gov Identifier: NCT00623857

Health Authority: Tanzania: National Institute for Medical Research