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Clinical Trials/NCT04657640
NCT04657640
Completed
Phase 3

Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso

Harvard School of Public Health (HSPH)1 site in 1 country3,123 target enrollmentDecember 11, 2020
ConditionsAnemia

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Anemia
Sponsor
Harvard School of Public Health (HSPH)
Enrollment
3123
Locations
1
Primary Endpoint
Anemia Status
Status
Completed
Last Updated
last year

Overview

Brief Summary

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status, school performance/attendance and development outcomes among adolescents in Burkina Faso.

Detailed Description

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Burkina Faso. Findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in Burkina Faso. This will be a cluster randomized study with 3 arms. 42 schools per country will be enrolled (14 schools per arm) to receive either 1) daily Multiple Micronutrient Supplements (MMS) and weekly Iron and Folic Acid (IFA) for the first 5 weeks and daily MMS for the remainder of the study; or 2) weekly IFA; or 3) to serve as controls. As recommended by the World Health Organization in settings where continuous supplementation is not possible, supplementation will be intermittent. Supplementation will be provided for 3 months, stopped for 3 months over the school summer holidays and resumed for 3 months once students return to school after the holiday. Students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene \[WASH\]). The program will be evaluated comparing effects of weekly IFA and daily MMS on anemia status and school attendance/retention.

Registry
clinicaltrials.gov
Start Date
December 11, 2020
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Responsible Party
Principal Investigator
Principal Investigator

Wafaie Fawzi

Professor of Nutrition, Epidemiology, and Global Health

Harvard School of Public Health (HSPH)

Eligibility Criteria

Inclusion Criteria

  • Adolescents aged 10-17 years
  • Enrolled in secondary school form 1 at study initiation
  • Member of one of the selected classes in a participating school
  • Consent provided by the parent
  • Assent provided by the adolescent
  • Fluency in French

Exclusion Criteria

  • No informed consent from parent or assent from adolescent
  • Self-reported Pregnancy

Outcomes

Primary Outcomes

Anemia Status

Time Frame: Up to one year

Anemia will be defined as hemoglobin level \<10 g/dL

Secondary Outcomes

  • School attendance(Up to one year)
  • School retention(Up to one year)

Study Sites (1)

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