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Micronutrients and Child Health Study (MACH)

This study has been completed.
Sponsor:
Collaborator:
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT00623857
First received: February 14, 2008
Last updated: November 14, 2014
Last verified: November 2014

February 14, 2008
November 14, 2014
March 2008
March 2009   (final data collection date for primary outcome measure)
Febrile malaria episodes [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623857 on ClinicalTrials.gov Archive Site
  • Haematologic and urinary indicators of micronutrient status [ Time Frame: 30 weeks after start of intervention ] [ Designated as safety issue: Yes ]
  • Anthropometric indices [ Time Frame: 57 weeks after start of intervention ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Plasma immunoglobulin concentrations [ Time Frame: 2 weeks after malaria episodes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Micronutrients and Child Health Study
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Malaria
  • 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
  • Active Comparator: 1
    Zinc
    Intervention: Dietary Supplement: Zinc
  • Active Comparator: 2
    Vitamins and minerals other than zinc
    Intervention: Dietary Supplement: Vitamins and minerals other than zinc
  • Active Comparator: 3
    Vitamins plus zinc and other minerals
    Intervention: Dietary Supplement: Vitamins plus zinc and other minerals
  • Placebo Comparator: 4
    Placebo for all vitamins and minerals
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
612
March 2009
March 2009   (final data collection date for primary outcome measure)

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)
Both
6 Months to 60 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00623857
WAO 93-442
Yes
Wageningen University
Wageningen University
Kilimanjaro Christian Medical Centre, Tanzania
Principal Investigator: Hans Verhoef, PhD Wageningen University, Cell Biology and Immunology Group
Study Chair: Raimos M Olomi, MD MMed MPH Kilimanjaro Christian Medical Centre
Study Director: Huub FJ Savelkoul, PhD Wageningen University, Cell Biology and Immunology Group
Study Director: John F. Shao, MD Kilimanjaro Christian Medical Centre
Wageningen University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP