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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-12-30

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.

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Weekly IFA

Receive weekly IFA

Group Type EXPERIMENTAL

Iron and folic acid (IFA)

Intervention Type DIETARY_SUPPLEMENT

IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)

Daily MMS

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

Group Type EXPERIMENTAL

Multiple Micronutrient Supplement (MMS)

Intervention Type DIETARY_SUPPLEMENT

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).

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Iron and folic acid (IFA)

IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)

Intervention Type DIETARY_SUPPLEMENT

Multiple Micronutrient Supplement (MMS)

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).

Intervention Type DIETARY_SUPPLEMENT

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