Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

July 11, 2018 updated by: University of California, Davis

Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso

Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea.

The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities.

Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months.

The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.

Study Type

Interventional

Enrollment (Actual)

7680

Phase

  • Not Applicable

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

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso
        • Institut de Recherche en Science de la Sante

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

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6-27 months of age
  • Plan to remain in study area for 1 year

Exclusion Criteria:

  • Evidence of congenital abnormalities and chronic infection
  • Severe anemia and severe acute malnutrition
  • Consumption of micronutrient supplementation including zinc

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Daily preventive Zn; placebo treatment
7 mg zinc per day for 12 months and placebo supplement during diarrhea episode
Dietary supplement: Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
Other Names:
  • Nutriset preventive zinc and therapeutic placebo supplement
EXPERIMENTAL: Therapeutic Zn; daily placebo
20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement
Dietary supplement: Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement
Other Names:
  • Nutriset ZinCfant
EXPERIMENTAL: Intermittent Zn; placebo treatment
10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode
Dietary supplement: Intermittent Zn; placebo treatment
10 mg zinc for 10 days every 3 months, placebo supplements daily for all other days during 12 months; placebo supplements during diarrhea episodes
Other Names:
  • Nutriset zinc supplement
ACTIVE_COMPARATOR: Surveillance control group
Surveillance control group will be randomly assigned to intervention groups every 3 months
Other: Surveillance control group
Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months
NO_INTERVENTION: Non-intervention
Standard care provided by health system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in length and length-for-age Z-score
Time Frame: 12 months
12 months
Change in weight and weight-for-age
Time Frame: 12 months
12 months
Incidence of diarrhea and laboratory-confirmed malaria
Time Frame: 12 months
12 months
Change in plasma zinc concentration
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of stunting, underweight, and wasting
Time Frame: 12 months
12 months
Change in hemoglobin and iron status
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University of California, Davis

Collaborators

Helen Keller International
Thrasher Research Fund
Université Polytechnique de Bobo-Dioulasso
Canadian International Development Agency

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

December 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (ESTIMATE)

July 23, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222218
  • Zinc 7-20

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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