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

Study Overview
=================
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.

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.

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

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)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation; daily multiple micronutrient supplements (MMS); or control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weekly iron and folic acid supplementation (IFA)<br> | Dietary Supplement: Iron and folic acid (IFA)<br>* Weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 μg) for 3 months intermittently<br>|
| Experimental: daily multiple micronutrient supplement (MMS)<br> | Dietary Supplement: Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)<br>* 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.<br>|
| No Intervention: control<br> | |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Micronutrient Supplementation, Iron and Folic Acid, Nutrition, Adolescent Health