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Completed

NCT Number: NCT00623857

Micronutrients and Child Health Study

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.

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Key information

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Zinc

Dietary Supplement

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

Vitamins and minerals other than zinc

Dietary 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 minerals

Dietary 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

Placebo

Dietary Supplement

Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

Primary outcomes

  1. Febrile malaria episodes

    Time frame: 60 weeks

Secondary outcomes

  1. Haematologic and urinary indicators of micronutrient status

    Time frame: 30 weeks after start of intervention

  2. Anthropometric indices

    Time frame: 57 weeks after start of intervention

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

    Time frame: 30 weeks after start of intervention

  4. Plasma immunoglobulin concentrations

    Time frame: 2 weeks after malaria episodes

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania

Registry information

Official study title

Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children

Acronym: MACH

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 26, 2008
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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