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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Dietary supplement: Iron and folic acid (IFA); Dietary supplement: Multiple Micronutrient Supplement (MMS)

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 Type: Interventional
• Enrollment (Actual): 2480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Zanzibar
    • Welezo, Zanzibar, Tanzania
      • Zanzibar Association for People Living with HIV/AIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Weekly IFA; Receive weekly IFA	Dietary supplement: Iron and folic acid (IFA); IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)
Experimental: Daily MMS; Receive daily MMS (including iron and folic acid as components)	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Africa Academy for Public Health; Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)
• Investigators: Principal Investigator: Wafaie W Fawzi, MBBS, MPH, MS, DrPH, Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Anemia; Nutrition; Adolescent Health; Multiple Micronutrient Supplementation (MMS); Iron and Folic Acid (IFA)
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Vitamins; Vitamin B Complex; Hematinics; Micronutrients; Trace Elements; Folic Acid
• Other Study ID Numbers: IRB20-1108-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No