School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso

Phase 3

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Iron and folic acid (IFA); Dietary Supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)

• Registration Number: NCT04657640
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2020-12-11
• Primary Completion: 2023-10-31
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
weekly iron and folic acid supplementation (IFA)	Iron and folic acid (IFA)	-
daily multiple micronutrient supplement (MMS)	Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)	-

Primary Outcome Measures

Name	Time	Method
Anemia Status	Up to one year	Anemia will be defined as hemoglobin level \<10 g/dL

Secondary Outcome Measures

Name	Time	Method
School attendance	Up to one year	School attendance will be measured as number of days of missed school per student
School retention	Up to one year	School retention will be measured as number of students who drop out of school

Trial Locations

Locations (1)

Nouna Health Research Center; 🇧🇫 Nouna, Burkina Faso