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

Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia
• Intervention / Treatment: Dietary supplement: Iron and folic acid (IFA); Dietary supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)

Detailed Description

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Burkina Faso. 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 Burkina Faso.

This will be a cluster randomized study with 3 arms. 42 schools per country will be enrolled (14 schools per arm) to receive either 1) daily Multiple Micronutrient Supplements (MMS) and weekly Iron and Folic Acid (IFA) for the first 5 weeks and daily MMS for the remainder of the study; or 2) weekly IFA; or 3) to serve as controls. As recommended by the World Health Organization in settings where continuous supplementation is not possible, supplementation will be intermittent. Supplementation will be provided for 3 months, stopped for 3 months over the school summer holidays and resumed for 3 months once students return to school after the holiday. 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 comparing effects of weekly IFA and daily MMS on anemia status and school attendance/retention.

• Study Type: Interventional
• Enrollment (Anticipated): 2100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Burkina Faso
  • Nouna, Burkina Faso
    • Nouna Health Research Center

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 French

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 iron and folic acid supplementation (IFA)	Dietary supplement: Iron and folic acid (IFA); Weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 μg) for 3 months intermittently
Experimental: daily multiple micronutrient supplement (MMS)	Dietary supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia Status	Anemia will be defined as hemoglobin level <10 g/dL	Up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
School attendance	School attendance will be measured as number of days of missed school per student	Up to one year
School retention	School retention will be measured as number of students who drop out of school	Up to one year

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Centre de Recherche en Sante de Nouna, Burkina Faso
• Investigators: Principal Investigator: Wafaie W Wafaie, MBBS, MPH, MS, DrPH, Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

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

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