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

Anemia Clinical Trial

— SAMIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104554
• Other study ID #: IRB20-1108-2
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 school performance/attendance among in-school adolescents in Zanzibar, Tanzania.

Description:

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Zanzibar. 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 Zanzibar. This will be a cluster randomized study with 3 arms. At the beginning of the academic year, 42 schools will be enrolled (14 schools per arm) to receive either 1) supplementation with weekly iron and folic acid (IFA); 2) supplementation with daily multiple micronutrient supplements (MMS) (including iron and folic acid as components); or 3) to serve as controls. 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 at the end of year 1, comparing effects of weekly IFA and daily MMS on anemia status and school attendance/performance. The more effective strategy (MMS or IFA) will be scaled up to all the study schools for year 2 of the intervention, and the outcomes will be re-assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2480
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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 Swahili and/or English

Exclusion Criteria:

• No informed consent from parent or assent from adolescent
• Self-reported pregnancy

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Iron and folic acid (IFA)
IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 µg)
• Multiple Micronutrient Supplement (MMS)
MMS: Daily regimen of one multiple micronutrient tablet containing fifteen micronutrients in the United Nations International Multiple Micronutrient Preparation (UNIMMAP) preparation. Composition includes vitamin A (800 ug), vitamin D (5 ug), vitamin E (10 mg), vitamin C (70 mg), vitamin B1 (1.4 mg), vitamin B2 (1.4 mg), niacin (18 mg), vitamin B6 (1.9 mg), vitamin B12 (2.6 ug), folic acid (400 ug), iron (30 mg), zinc (15 mg), copper (2 mg), selenium (65 ug), and iodine (150 ug).

Locations

Country	Name	City	State
Tanzania	Zanzibar Association for People Living with HIV/AIDS	Welezo	Zanzibar

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Africa Academy for Public Health, Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia status	Anemia will be defined based on the sex- and age- specific WHO cutoffs: Children 12-14 years: < 120 g/L; Non-pregnant women = 15 years: < 120 g/L; Pregnant women: < 110 g/L; Men = 15 years: < 130 g/L	Up to one year
Secondary	School attendance	Number of days of missed school per student	Up to one year
Secondary	School retention	Number of students who drop out of school	Up to one year
Secondary	School performance	Percent of students who pass to the next grade at the end of the year	Up to one year