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

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ClinicalTrials.gov Identifier: NCT04657640
Recruitment Status : Active, not recruiting
First Posted : December 8, 2020
Last Update Posted : October 18, 2022
Sponsor:
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health (HSPH)

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : December 11, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Anemia Status [ Time Frame: Up to one year ]
    Anemia will be defined as hemoglobin level <10 g/dL


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657640


Locations
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Burkina Faso
Nouna Health Research Center
Nouna, Burkina Faso
Sponsors and Collaborators
Harvard School of Public Health (HSPH)
Centre de Recherche en Sante de Nouna, Burkina Faso
Investigators
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Principal Investigator: Wafaie W Wafaie, MBBS, MPH, MS, DrPH Harvard School of Public Health (HSPH)
More Information
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Responsible Party: Wafaie Fawzi, Professor of Nutrition, Epidemiology, and Global Health, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier: NCT04657640    
Other Study ID Numbers: IRB20-1108
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wafaie Fawzi, Harvard School of Public Health (HSPH):
Multiple Micronutrient Supplementation
Iron and Folic Acid
Nutrition
Adolescent Health
Additional relevant MeSH terms:
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Iron
Trace Elements
Folic Acid
Micronutrients
 Vitamin B Complex
Physiological Effects of Drugs
Hematinics
Vitamins