Micronutrients and Child Health Study (MACH)

November 14, 2014 updated by: Wageningen University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

612

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Zinc
Dietary supplement: Zinc
Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
Active Comparator: 2
Vitamins and minerals other than zinc
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
Active Comparator: 3
Vitamins plus zinc and other minerals
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
Placebo Comparator: 4
Placebo for all vitamins and minerals
Dietary supplement: Placebo
Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Febrile malaria episodes
Time Frame: 60 weeks
60 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Haematologic and urinary indicators of micronutrient status
Time Frame: 30 weeks after start of intervention
30 weeks after start of intervention
Anthropometric indices
Time Frame: 57 weeks after start of intervention
57 weeks after start of intervention
T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate
Time Frame: 30 weeks after start of intervention
30 weeks after start of intervention
Plasma immunoglobulin concentrations
Time Frame: 2 weeks after malaria episodes
2 weeks after malaria episodes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

Kilimanjaro Christian Medical Centre, Tanzania

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WAO 93-442

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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