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Completed

NCT Number: NCT04657640

School-Based Assessment of Micronutrient Interventions in Adolescents 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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nouna Health Research Center

Nouna, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron and Folic Acid (IFA)

Dietary Supplement

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)

Dietary Supplement

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.

Primary outcomes

  1. Anemia Status

    Time frame: Up to one year

    Anemia will be defined as hemoglobin level <10 g/dL

Secondary outcomes

  1. School attendance

    Time frame: Up to one year

    School attendance will be measured as number of days of missed school per student

  2. School retention

    Time frame: Up to one year

    School retention will be measured as number of students who drop out of school

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Centre de Recherche en Sante de Nouna, Burkina Faso

Registry information

Official study title

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

Acronym: SAMIA

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 8, 2020
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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