Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944359
• Other study ID #: 222218
• Secondary ID: Zinc 7-20
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: July 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7680
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 27 Months

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Malaria
• Zinc Deficiency

Intervention

Dietary Supplement:
• Daily preventive Zn; placebo treatment
7 mg zinc / day and placebo supplement during diarrhea episodes
• Therapeutic Zn; daily placebo
20 mg zinc / day for 10 days during diarrhea episodes and daily placebo 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

Locations

Country	Name	City	State
Burkina Faso	Institut de Recherche en Science de la Sante	Bobo-Dioulasso

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Davis	Canadian International Development Agency, Helen Keller International, Thrasher Research Fund, Université Polytechnique de Bobo-Dioulasso

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (2)

Becquey E, Ouédraogo CT, Hess SY, Rouamba N, Prince L, Ouédraogo JB, Vosti SA, Brown KH. Comparison of Preventive and Therapeutic Zinc Supplementation in Young Children in Burkina Faso: A Cluster-Randomized, Community-Based Trial. J Nutr. 2016 Oct;146(10) — View Citation

Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouédraogo CT, Somé JW, Yakes Jimenez E, Ouédraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in length and length-for-age Z-score		12 months
Primary	Change in weight and weight-for-age		12 months
Primary	Incidence of diarrhea and laboratory-confirmed malaria		12 months
Primary	Change in plasma zinc concentration		12 months
Secondary	Incidence of stunting, underweight, and wasting		12 months
Secondary	Change in hemoglobin and iron status		12 months