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

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04657640

Collaborator

Centre de Recherche en Sante de Nouna, Burkina Faso (Other)

2,100

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

112.9

Patients Per Site Per Month

Study Details

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, school performance/attendance and development outcomes among adolescents in Burkina Faso.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Dietary Supplement: Iron and folic acid (IFA) Dietary Supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation; daily multiple micronutrient supplements (MMS); or control.Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation; daily multiple micronutrient supplements (MMS); or control.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 11, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: control

Arm

Intervention/Treatment

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.

No Intervention: control

Outcome Measures

Primary Outcome Measures

Anemia Status [Up to one year]
Anemia will be defined as hemoglobin level <10 g/dL

Secondary Outcome Measures

School attendance [Up to one year]
School attendance will be measured as number of days of missed school per student
School retention [Up to one year]
School retention will be measured as number of students who drop out of school