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

NCT05104554 | Completed

• 1 other identifier: IRB20-1108-2
• Study Type: interventional
• Target: 2,480
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Anemia status

  Anemia 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

  Up to one year

Secondary Outcomes (3)

• School attendance

  Up to one year

• School retention

  Up to one year

• School performance

  Up to one year

Study Arms (3)

Weekly IFA

EXPERIMENTAL

Receive weekly IFA

Dietary Supplement: Iron and folic acid (IFA)

Daily MMS

EXPERIMENTAL

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

Dietary Supplement: Multiple Micronutrient Supplement (MMS)

Control

NO INTERVENTION

Interventions

Iron and folic acid (IFA) DIETARY_SUPPLEMENT

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

Weekly IFA

Multiple Micronutrient Supplement (MMS) 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).

Daily MMS

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• No informed consent from parent or assent from adolescent
• Self-reported pregnancy

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Africa Academy for Public Health: collaborator
• Zanzibar Association of People Living with HIV/AIDS (ZAPHA+): collaborator

Study Sites (1)

Zanzibar Association for People Living with HIV/AIDS

Welezo, Zanzibar, Tanzania

Location

Related Publications (2)

• Yusufu I, Cliffer IR, Yussuf MH, Anthony C, Mapendo F, Abdulla S, Masanja M, Tinkasimile A, Ali AS, Mwanyika-Sando M, Fawzi W. Factors associated with anemia among school-going adolescents aged 10-17 years in Zanzibar, Tanzania: a cross sectional study. BMC Public Health. 2023 Sep 18;23(1):1814. doi: 10.1186/s12889-023-16611-w.

  PMID: 37723498 DERIVED

• Cliffer IR, Yussuf MH, Millogo O, Mwanyika-Sando M, Barry Y, Yusufu IS, Hemler EC, Sie A, Tinkasimile A, Compaore G, Ali AS, Kouanda I, Wang D, Mosha D, Fawzi W. Scaling-up high-impact micronutrient supplementation interventions to improve adolescents' nutrition and health in Burkina Faso and Tanzania: protocol for a cluster-randomised controlled trial. BMJ Open. 2023 Feb 15;13(2):e063686. doi: 10.1136/bmjopen-2022-063686.

  PMID: 36792333 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Iron; Folic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wafaie W Fawzi, MBBS, MPH, MS, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition, Epidemiology, and Global Health

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 3, 2021
• Study Start: March 10, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)