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Completed

NCT Number: NCT06815315

Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

13 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

World Vision Monapo Field Office

Monapo, Nampula, Mozambique

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Treatment and study plan

Multiple micronutrient supplementation

Dietary Supplement

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.

Iron Folic Acid Supplementation

Dietary Supplement

One IFAS tablet contains Iron (60 mg) and Folic Acid (2800 μg) and is taken weekly.

Adolescent Nutrition Curriculum

Behavioral

The Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods.

Primary outcomes

  1. Anemia Status

    Time frame: 6 months

    Anemia is defined as hemoglobin level <10 g/dL

Secondary outcomes

  1. Anemia Knowledge

    Time frame: 6 months

    Changes in knowledge from baseline to endline around anemia causes and strategies to prevent anemia.

  2. Minimum Dietary Diversity Score

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

World Vision US

Other

Registry information

Official study title

A Formative, Mixed-Methods Evaluation Assessing the Acceptability, Feasibility, and Effectiveness of Micronutrient Interventions Among Adolescents in Mozambique

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

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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