School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso (SAMIA)

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04657640

IRB20-1108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,123 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,123 participants in 3 patient groups

weekly iron and folic acid supplementation (IFA)

Experimental group

Treatment:

Dietary Supplement: Iron and folic acid (IFA)

daily multiple micronutrient supplement (MMS)

Experimental group

Treatment:

Dietary Supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)

control

No Intervention group