School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso

NCT04657640 | Completed Phase 3

• 1 other identifier: IRB20-1108
• Study Type: interventional
• Target: 3,123
• 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, school performance/attendance and development outcomes among adolescents in Burkina Faso.

Conditions

Anemia

Keywords

Multiple Micronutrient Supplementation; Iron and Folic Acid; Nutrition; Adolescent Health

Outcome Measures

Primary Outcomes (1)

• Anemia Status

  Anemia will be defined as hemoglobin level \<10 g/dL

  Up to one year

Secondary Outcomes (2)

• School attendance

  Up to one year

• School retention

  Up to one year

Study Arms (3)

weekly iron and folic acid supplementation (IFA)

EXPERIMENTAL

Dietary Supplement: Iron and folic acid (IFA)

daily multiple micronutrient supplement (MMS)

EXPERIMENTAL

Dietary Supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)

control

NO INTERVENTION

Interventions

Iron and folic acid (IFA) DIETARY_SUPPLEMENT

Weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 μg) for 3 months intermittently

weekly iron and folic acid supplementation (IFA)

Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA) DIETARY_SUPPLEMENT

Daily regimen of MMS for 3 months intermittently. MMS is the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) tablet containing fifteen micronutrients including iron (30mg), folic acid (400 mcg), Vit A, Retinol (800 RE), vit D (200 IU), vit E (10 mg), vit C (70 mg), vit B1 (1.4 mg), vit B2 (1.4 mg), vit B6 (1.9 mg), vit B12 (2.6 mcg), niacin (18 mg), zinc (15 mg), copper (2 mg), iodine (150 mcg), selenium (65 mcg). For the first 5 weeks of the study, participants will also receive weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 μg) as a loading dose, in addition to daily MMS.

daily multiple micronutrient supplement (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 French

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
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator

Study Sites (1)

Nouna Health Research Center

Nouna, Burkina Faso

Location

Related Publications (2)

• Cliffer IR, Millogo O, Barry Y, Kouanda I, Compaore G, Wang D, Sie A, Fawzi W. School-based supplementation with iron-folic acid or multiple micronutrient tablets to address anemia among adolescents in Burkina Faso: a cluster-randomized trial. Am J Clin Nutr. 2023 Nov;118(5):977-988. doi: 10.1016/j.ajcnut.2023.09.004. Epub 2023 Sep 15.

  PMID: 37716443 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 Wafaie, MBBS, MPH, MS, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 8, 2020
• Study Start: December 11, 2020
• Primary Completion: October 31, 2023
• Study Completion: April 30, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)