Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Anemia
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation; daily multiple micronutrient supplements (MMS); or control.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 10 years and 17 years
Gender
Both males and females

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 ...

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. At the beginning of the academic year, 42 schools per country will be enrolled (14 schools per arm) to receive either 1) supplementation with weekly iron and folic acid (IFA); 2) supplementation with daily multiple micronutrient supplements (MMS) (including IFA); or 3) to serve as controls. 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, school attendance/performance, and adolescent development outcomes.

Tracking Information

NCT #
NCT04657640
Collaborators
Centre de Recherche en Sante de Nouna, Burkina Faso
Investigators
Principal Investigator: Wafaie W Wafaie, MBBS, MPH, MS, DrPH Harvard School of Public Health