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

Anemia Clinical Trial

— SAMIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657640
• Other study ID #: IRB20-1108
• Status: Completed
• Phase: Phase 3
• Start date: December 11, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3123
• Est. completion date: April 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Iron and folic acid (IFA)
Weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 µg) for 3 months intermittently
• 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.

Locations

Country	Name	City	State
Burkina Faso	Nouna Health Research Center	Nouna

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Centre de Recherche en Sante de Nouna, Burkina Faso

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia Status	Anemia will be defined as hemoglobin level <10 g/dL	Up to one year
Secondary	School attendance	School attendance will be measured as number of days of missed school per student	Up to one year
Secondary	School retention	School retention will be measured as number of students who drop out of school	Up to one year