Clinical trial NCT00944359: Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
Official title: Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Diarrhea
Malaria
Keywords: zinc supplementation
diarrhea management
zinc deficiency
malaria
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Université Polytechnique de Bobo-Dioulasso
name: Helen Keller International
name: Thrasher Research Fund
name: Canadian International Development Agency
First posted: 2009-07-23
Enrollment: 7680
Sex: ALL
Minimum age (years): 6
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in length and length-for-age Z-score
timeFrame: 12 months
measure: Change in weight and weight-for-age
timeFrame: 12 months
measure: Incidence of diarrhea and laboratory-confirmed malaria
timeFrame: 12 months
measure: Change in plasma zinc concentration
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of stunting, underweight, and wasting
timeFrame: 12 months
measure: Change in hemoglobin and iron status
timeFrame: 12 months
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Institut de Recherche en Science de la Sante
Study officials:
affiliation: University of California, Davis
name: Kenneth H Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becquey E, Ouedraogo CT, Hess SY, Rouamba N, Prince L, Ouedraogo 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):2058-2066. doi: 10.3945/jn.116.230128. Epub 2016 Aug 3.
citation: Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouedraogo CT, Some JW, Yakes Jimenez E, Ouedraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS). PLoS One. 2017 Aug 3;12(8):e0181770. doi: 10.1371/journal.pone.0181770. eCollection 2017.