An interventional study of Multiple micronutrient supplementation and Iron Folic Acid Supplementation in Anemia, sponsored by World Vision US. Completed at 1 site in Mozambique. Open to female participants aged 13 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by World Vision US · Not applicable, Interventional, and Prevention
This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and the impact of a nutrition curriculum on diet diversity and anemia knowledge among adolescent girls.
This study aimed to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health, and education in Mozambique. In conjunction with the Mozambique Ministries of Health, Education and Culture, we conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm). Each club was comprised of around 18 girls aged 13 to 20 years. Using constrained sampling to balance for age and school, clubs were randomly assigned to one of two intervention groups: 1) Multiple Micronutrient Supplementation (MMS) for five months plus a Nutrition Curriculum, or 2) Iron and Folic Acid Supplementation (IFAS) plus a Nutrition Curriculum. Girls enrolled in the MMS arm consumed supplements daily for 4 months at home and weekly nutrition messages delivered through the clubs. Girls enrolled in the IFAS arm consumed supplements once a week for 4 months at school (the standard of care) and weekly nutrition messages delivered through the clubs. The study evaluated the effects of MMS and IFAS on anemia status and the impact of the nutrition curriculum on diet diversity and anemia knowledge.
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 490 is above the median of 96 across 1,318 interventional studies indexed under Anemia.
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Adolescents aged 13-20 years Enrolled in secondary school at study initiation Member of an IMPACT+ Girls Club at one of the participating schools Consent provided by the parent Assent provided by the adolescent
Exclusion Criteria:
No informed consent from parent or assent from adolescent Self-reported pregnancy
The adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages.
Dietary Supplement: Multiple micronutrient supplementation · Behavioral: Adolescent Nutrition Curriculum
The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages
Dietary Supplement: Iron Folic Acid Supplementation · Behavioral: Adolescent Nutrition Curriculum
The multiple micronutrient supplementation composition follows the United Nations International Multiple Micronutrient Antenatal Preparation. Each MMS tablet contains 15 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) and is consumed daily.
One IFAS tablet contains Iron (60 mg) and Folic Acid (2800 μg) and is taken weekly.
The Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods.
Anemia Status
Anemia is defined as hemoglobin level \<10 g/dL
Time frame: 6 months
Anemia Knowledge
Changes in knowledge from baseline to endline around anemia causes and strategies to prevent anemia.
Time frame: 6 months
Minimum Dietary Diversity Score
The minimum dietary diversity score measures girls and women who 10 possible food groups over a 24-hour recall period are classified as having minimally adequate diet diversity.
Time frame: 6 months
Plan to share: Undecided — With permission from the Mozambique Ministry of Health Commitee for Bioethics, the quantitative dataset supporting the conclusions of this study can be found in the Humanitarian Data Exchange at https://data.humdata.org.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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