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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05104554
Acronym
SAMIA
Enrollment
2480
Registered
2021-11-03
Start date
2022-03-10
Completion date
2023-12-30
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Anemia, Multiple Micronutrient Supplementation (MMS), Iron and Folic Acid (IFA), Nutrition, Adolescent Health

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.

Interventions

DIETARY_SUPPLEMENTIron and folic acid (IFA)

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

DIETARY_SUPPLEMENTMultiple 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).

Sponsors

Africa Academy for Public Health
CollaboratorOTHER
Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)
CollaboratorUNKNOWN
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anemia statusUp to one yearAnemia 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

MeasureTime frameDescription
School attendanceUp to one yearNumber of days of missed school per student
School retentionUp to one yearNumber of students who drop out of school
School performanceUp to one yearPercent of students who pass to the next grade at the end of the year

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026