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

Primary Purpose

Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Iron and folic acid (IFA)
Multiple Micronutrient Supplement (MMS)
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring Anemia, Multiple Micronutrient Supplementation (MMS), Iron and Folic Acid (IFA), Nutrition, Adolescent Health

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zanzibar Association for People Living with HIV/AIDSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Weekly IFA

Daily MMS

Control

Arm Description

Receive weekly IFA

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2021
Last Updated
June 18, 2023
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Africa Academy for Public Health, Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)
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1. Study Identification

Unique Protocol Identification Number
NCT05104554
Brief Title
School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
Acronym
SAMIA
Official Title
School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Africa Academy for Public Health, Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Multiple Micronutrient Supplementation (MMS), Iron and Folic Acid (IFA), Nutrition, Adolescent Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
2940 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weekly IFA
Arm Type
Experimental
Arm Description
Receive weekly IFA
Arm Title
Daily MMS
Arm Type
Experimental
Arm Description
Receive daily MMS (including iron and folic acid as components)
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron and folic acid (IFA)
Intervention Description
IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple Micronutrient Supplement (MMS)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Anemia status
Description
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
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
School attendance
Description
Number of days of missed school per student
Time Frame
Up to one year
Title
School retention
Description
Number of students who drop out of school
Time Frame
Up to one year
Title
School performance
Description
Percent of students who pass to the next grade at the end of the year
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaie Fawzi, MBBS, MPH, MS, DrPH
Phone
617 432 2086
Email
mina@hsph.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ilana R Cliffer, PhD, MPH
Phone
7039279472
Email
icliffer@hsph.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaie W Fawzi, MBBS, MPH, MS, DrPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zanzibar Association for People Living with HIV/AIDS
City
Welezo
State/Province
Zanzibar
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Salim Ali, MD
Email
alisalum@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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