Clinical trial NCT04657640: School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso
Official title: Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Multiple Micronutrient Supplementation
Iron and Folic Acid
Nutrition
Adolescent Health
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
First posted: 2020-12-08
Enrollment: 3123
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation; daily multiple micronutrient supplements (MMS); or control.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Anemia Status
timeFrame: Up to one year
Secondary outcomes:
measure: School attendance
timeFrame: Up to one year
measure: School retention
timeFrame: Up to one year
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Nouna Health Research Center
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Wafaie, MBBS, MPH, MS, DrPH
role: PRINCIPAL_INVESTIGATOR
References: