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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Iron and folic acid (IFA)
* Dietary Supplement: Multiple Micronutrient Supplement (MMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation, daily multiple micronutrient supplements (MMS), or control. Supplementation will be conducted continuously over the course of the first year. Baseline and end-line surveys will be conducted to collect demographic information and assess outcomes. In the second year of the study, the more effective supplementation strategy (IFA or MMS) will be scaled up to all study schools and the outcomes will be re-assessed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly IFA<br>Receive weekly IFA | Dietary Supplement: Iron and folic acid (IFA)<br>* IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)<br>|
| Experimental: Daily MMS<br>Receive daily MMS (including iron and folic acid as components) | Dietary Supplement: Multiple Micronutrient Supplement (MMS)<br>* MMS: Daily regimen of one multiple micronutrient tablet containing fifteen micronutrients in the United Nations International Multiple Micronutrient Preparation (UNIMMAP) preparation. Composition includes vitamin A (800 ug), vitamin D (5 ug), vitamin E (10 mg), vitamin C (70 mg), vitamin B1 (1.4 mg), vitamin B2 (1.4 mg), niacin (18 mg), vitamin B6 (1.9 mg), vitamin B12 (2.6 ug), folic acid (400 ug), iron (30 mg), zinc (15 mg), copper (2 mg), selenium (65 ug), and iodine (150 ug).<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia status | Anemia will be defined based on the sex- and age- specific WHO cutoffs: Children 12-14 years: < 120 g/L Non-pregnant women ≥ 15 years: < 120 g/L Pregnant women: < 110 g/L Men ≥ 15 years: < 130 g/L | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School attendance | Number of days of missed school per student | Up to one year | 
| School retention | Number of students who drop out of school | Up to one year | 
| School performance | Percent of students who pass to the next grade at the end of the year | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron and Folic Acid (IFA), Adolescent Health, Anemia, Multiple Micronutrient Supplementation (MMS), Nutrition