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

President and Fellows of Harvard College

Status: Completed

Conditions: Anemia

Treatments: Dietary Supplement: Iron and folic acid (IFA); Dietary Supplement: Multiple Micronutrient Supplement (MMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05104554

IRB20-1108-2

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 and school performance/attendance among in-school adolescents in Zanzibar, Tanzania.

Full description

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Zanzibar. 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 Zanzibar.

This will be a cluster randomized study with 3 arms. At the beginning of the academic year, 42 schools 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 iron and folic acid as components); 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 at the end of year 1, comparing effects of weekly IFA and daily MMS on anemia status and school attendance/performance. The more effective strategy (MMS or IFA) will be scaled up to all the study schools for year 2 of the intervention, and the outcomes will be re-assessed.

Enrollment: 2,480 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 Swahili and/or English

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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2,480 participants in 3 patient groups

Weekly IFA

Experimental group

Description:

Receive weekly IFA

Treatment:

Dietary Supplement: Iron and folic acid (IFA)

Daily MMS

Experimental group

Description:

Receive daily MMS (including iron and folic acid as components)

Treatment:

Dietary Supplement: Multiple Micronutrient Supplement (MMS)

Control

No Intervention group