Clinical trial NCT05104554: School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
Official title: School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Multiple Micronutrient Supplementation (MMS)
Iron and Folic Acid (IFA)
Nutrition
Adolescent Health
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Africa Academy for Public Health
name: Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)
First posted: 2021-11-03
Enrollment: 2480
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Schools will be randomly assigned to weekly iron and folic acid (IFA) supplementation, daily multiple micronutrient supplements (MMS), or control. Supplementation will be conducted continuously over the course of the first year. Baseline and end-line surveys will be conducted to collect demographic information and assess outcomes. In the second year of the study, the more effective supplementation strategy (IFA or MMS) will be scaled up to all study schools and the outcomes will be re-assessed.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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 Swahili and/or English

Exclusion Criteria:

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

Primary outcomes:
measure: Anemia status
timeFrame: Up to one year
Secondary outcomes:
measure: School attendance
timeFrame: Up to one year
measure: School retention
timeFrame: Up to one year
measure: School performance
timeFrame: Up to one year
Other outcomes:
Locations:
city: Welezo
country: Tanzania
facility: Zanzibar Association for People Living with HIV/AIDS
state: Zanzibar
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MBBS, MPH, MS, DrPH
role: PRINCIPAL_INVESTIGATOR
References: