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

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Multiple Micronutrient Supplement (MMS); Dietary Supplement: Iron and folic acid (IFA)

• Registration Number: NCT05104554
• 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 and school performance/attendance among in-school adolescents in Zanzibar, Tanzania.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-03
• Study Start: 2022-03-10
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily MMS	Multiple Micronutrient Supplement (MMS)	Receive daily MMS (including iron and folic acid as components)
Weekly IFA	Iron and folic acid (IFA)	Receive weekly IFA

Primary Outcome Measures

Name	Time	Method
Anemia status	Up to one year	Anemia will be defined based on the sex- and age- specific WHO cutoffs: 1. Children 12-14 years: \< 120 g/L; 2. Non-pregnant women ≥ 15 years: \< 120 g/L; 3. Pregnant women: \< 110 g/L; 4. Men ≥ 15 years: \< 130 g/L

Secondary Outcome Measures

Name	Time	Method
School performance	Up to one year	Percent of students who pass to the next grade at the end of the year
School retention	Up to one year	Number of students who drop out of school
School attendance	Up to one year	Number of days of missed school per student

Trial Locations

Locations (1)

Zanzibar Association for People Living with HIV/AIDS; 🇹🇿 Welezo, Zanzibar, Tanzania