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Completed

NCT Number: NCT00944359

Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

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.

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Key information

Conditions

Zinc Deficiency Diarrhea Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Pathological Conditions, Signs and Symptoms Protozoan Infections Signs and Symptoms Signs and Symptoms, Digestive Vector Borne Diseases

Age range

6 month–27 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche en Science de la Sante

Bobo-Dioulasso, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Daily preventive Zn; placebo treatment

Dietary Supplement

7 mg zinc / day and placebo supplement during diarrhea episodes

Other names: Nutriset preventive zinc and therapeutic placebo supplement

Therapeutic Zn; daily placebo

Dietary Supplement

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

Other names: Nutriset ZinCfant

Intermittent Zn; placebo treatment

Dietary Supplement

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

Surveillance control group

Other

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

Primary outcomes

  1. Change in length and length-for-age Z-score

    Time frame: 12 months

  2. Change in weight and weight-for-age

    Time frame: 12 months

  3. Incidence of diarrhea and laboratory-confirmed malaria

    Time frame: 12 months

  4. Change in plasma zinc concentration

    Time frame: 12 months

Secondary outcomes

  1. Incidence of stunting, underweight, and wasting

    Time frame: 12 months

  2. Change in hemoglobin and iron status

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 23, 2009
Registry last updated
Jul 13, 2018

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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