Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

NCT00944359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7680

Last updated 2018-07-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Daily preventive Zn; placebo treatment

7 mg zinc / day and placebo supplement during diarrhea episodes

DIETARY_SUPPLEMENT

Therapeutic Zn; daily placebo

20 mg zinc / day for 10 days during diarrhea episodes and daily placebo supplement

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

Surveillance control group

Active weekly morbidity surveillance for 3 months. New surveillance control group will be randomly assigned to intervention groups every 3 months

Sponsors & Collaborators

  • Université Polytechnique de Bobo-Dioulasso

    collaborator OTHER
  • Helen Keller International

    collaborator OTHER
  • Thrasher Research Fund

    collaborator OTHER
  • Canadian International Development Agency

    collaborator OTHER_GOV
  • University of California, Davis

    lead OTHER

Principal Investigators

  • Kenneth H Brown, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
27 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Burkina Faso

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944359 on ClinicalTrials.gov