AnemiaNCT06815315
Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique
A study testing Multiple micronutrient supplementation, Iron Folic Acid Supplementation and Adolescent Nutrition Curriculum in people with Anemia, run by World Vision US at 1 site in Mozambique.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Multiple micronutrient supplementation, Iron Folic Acid Supplementation and Adolescent Nutrition Curriculum
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- No informed consent from parent or assent from adolescent Self-reported pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Formative, Mixed-Methods Evaluation Assessing the Acceptability, Feasibility, and Effectiveness 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.
Read the detailed description
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.
- Conditions
- Anemia
- Being tested
- Multiple micronutrient supplementation, Iron Folic Acid Supplementation, Adolescent Nutrition Curriculum
- Keywords
- Vitamins, Supplements, Iron, Folic Acid, Mozambique, Micronutrients, Adolescents
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplementationDietary 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 SupplementationDietary supplement
One IFAS tablet contains Iron (60 mg) and Folic Acid (2800 μg) and is taken weekly.
Adolescent Nutrition CurriculumBehavioural
The Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Micronutrient Supplementation (MMS) Arm | Active comparator | The adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages. Receives: Dietary Supplement: Multiple micronutrient supplementation; Behavioral: Adolescent Nutrition Curriculum |
| Iron Folic Acid Supplementation (IFAS) Arm | Active comparator | The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages Receives: Dietary Supplement: Iron Folic Acid Supplementation; Behavioral: Adolescent Nutrition Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia Status
Anemia is defined as hemoglobin level <10 g/dL
Measured: 6 months
Secondary outcomes (2)
Anemia Knowledge
Changes in knowledge from baseline to endline around anemia causes and strategies to prevent anemia.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm), with each club consisting of approximately 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.
- Masking
- None (open label)
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Vision US
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah A Bauler, DrPH(c), Principal investigator, World Vision International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815315
- Sponsor's protocol ID
- WorldVision
- Other IDs
- 218961
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Formative, Mixed-Methods Evaluation Assessing the Acceptability, Feasibility, and Effectiveness of Micronutrient Interventions Among Adolescents in Mozambique
- ClinicalTrials.gov ID
- NCT06815315
- Acronym / sponsor ID
- WorldVision
- Conditions
- Anemia
- Keywords
- Vitamins, Supplements, Iron, Folic Acid, Mozambique, Micronutrients, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- World Vision USUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm), with each club consisting of approximately 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.
| Arm | Type | Receives |
|---|---|---|
| Multiple Micronutrient Supplementation (MMS) Arm | Active comparator | Dietary Supplement: Multiple micronutrient supplementation, Behavioral: Adolescent Nutrition CurriculumThe adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages. |
| Iron Folic Acid Supplementation (IFAS) Arm | Active comparator | Dietary Supplement: Iron Folic Acid Supplementation, Behavioral: Adolescent Nutrition CurriculumThe adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- No informed consent from parent or assent from adolescent Self-reported pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple micronutrient supplementationThe 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. | Dietary supplement | Multiple Micronutrient Supplementation (MMS) Arm |
| Iron Folic Acid SupplementationOne IFAS tablet contains Iron (60 mg) and Folic Acid (2800 μg) and is taken weekly. | Dietary supplement | Iron Folic Acid Supplementation (IFAS) Arm |
| Adolescent Nutrition CurriculumThe Adolescent Nutrition Curriculum includes five modules focused on promoting healthy behaviors to enhance nutrition, with an emphasis on consuming iron-rich foods. | Behavioural | Iron Folic Acid Supplementation (IFAS) Arm, Multiple Micronutrient Supplementation (MMS) Arm |
Primary outcome
Anemia Status
Time frame: 6 months
Anemia is defined as hemoglobin level <10 g/dL
2 secondary outcomes
Anemia Knowledge
Time frame: 6 months
Minimum Dietary Diversity Score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- The paper on photovoice published in the Emergency Nutrition Action Field Exchange describes the methodology and findings we used to develop and refine the Nutrition Curriculum. The Nutrition Curriculum is one of the interventions tested in this CRT.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Bauler, DrPH(c) principal investigator
World Vision International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient supplementation, Iron Folic Acid Supplementation and Adolescent Nutrition Curriculum in people with Anemia, run by World Vision US at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia Status (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.