AnemiaSAMIANCT05104554
School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
A study testing Iron and folic acid (IFA) and Multiple Micronutrient Supplement (MMS) in people with Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Iron and folic acid (IFA) and Multiple Micronutrient Supplement (MMS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- 1 siteTanzania
- Study dates
- 10 Mar 2022to 30 Dec 2023
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- No informed consent from parent or assent from adolescent
- Self-reported pregnancy
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Zanzibar Association for People Living with HIV/AIDS
Welezo, Zanzibar
About this study
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Iron and folic acid (IFA), Multiple Micronutrient Supplement (MMS)
- Keywords
- Anemia, Multiple Micronutrient Supplementation (MMS), Iron and Folic Acid (IFA), Nutrition, Adolescent Health
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron and folic acid (IFA)Dietary supplement
IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)
Multiple Micronutrient Supplement (MMS)Dietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Weekly IFA | Experimental | Receive weekly IFA Receives: Dietary Supplement: Iron and folic acid (IFA) |
| Daily MMS | Experimental | Receive daily MMS (including iron and folic acid as components) Receives: Dietary Supplement: Multiple Micronutrient Supplement (MMS) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to one year
Secondary outcomes (3)
School attendance
Number of days of missed school per student
Measured: Up to one year
School retention
Number of students who drop out of school
Measured: Up to one year
School performance
Percent of students who pass to the next grade at the end of the year
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start10 Mar 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 2,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Academy for Public Health, Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MBBS, MPH, MS, DrPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104554
- Sponsor's protocol ID
- IRB20-1108-2
- Acronym
- SAMIA
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yusufu I, Cliffer IR, Yussuf MH, Anthony C, Mapendo F, Abdulla S, Masanja M, Tinkasimile A, Ali AS, Mwanyika-Sando M, Fawzi W. Factors associated with anemia among school-going adolescents aged 10-17 years in Zanzibar, Tanzania: a cross sectional study. BMC Public Health. 2023 Sep 18;23(1):1814. doi: 10.1186/s12889-023-16611-w.
PubMed 37723498Cliffer IR, Yussuf MH, Millogo O, Mwanyika-Sando M, Barry Y, Yusufu IS, Hemler EC, Sie A, Tinkasimile A, Compaore G, Ali AS, Kouanda I, Wang D, Mosha D, Fawzi W. Scaling-up high-impact micronutrient supplementation interventions to improve adolescents' nutrition and health in Burkina Faso and Tanzania: protocol for a cluster-randomised controlled trial. BMJ Open. 2023 Feb 15;13(2):e063686. doi: 10.1136/bmjopen-2022-063686.
PubMed 36792333
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar
- ClinicalTrials.gov ID
- NCT05104554
- Acronym / sponsor ID
- SAMIA / IRB20-1108-2
- Conditions
- Anemia
- Keywords
- Anemia, Multiple Micronutrient Supplementation (MMS), Iron and Folic Acid (IFA), Nutrition, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,480 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Africa Academy for Public Health, Zanzibar Association of People Living with HIV/AIDS (ZAPHA+)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 3 Nov 2021 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Weekly IFA | Experimental | Dietary Supplement: Iron and folic acid (IFA)Receive weekly IFA |
| Daily MMS | Experimental | Dietary Supplement: Multiple Micronutrient Supplement (MMS)Receive daily MMS (including iron and folic acid as components) |
| Control | No intervention | – |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 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 |
|---|---|---|
| Iron and folic acid (IFA)IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg) | Dietary supplement | Weekly IFA |
| 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). | Dietary supplement | Daily MMS |
Primary outcome
Anemia status
Time frame: Up to one year
Anemia will be defined based on the sex- and age- specific WHO cutoffs: 1. Children 12-14 years: < 120 g/L 2. Non-pregnant women ≥ 15 years: < 120 g/L 3. Pregnant women: < 110 g/L 4. Men ≥ 15 years: < 130 g/L
3 secondary outcomes
School attendance
Time frame: Up to one year
School retention
Time frame: Up to one year
School performance
Time frame: Up to one year
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 28 Feb 2024.
- Derived from this study: PubMed 37723498Yusufu I, Cliffer IR, Yussuf MH, Anthony C, Mapendo F, Abdulla S, Masanja M, Tinkasimile A, Ali AS, Mwanyika-Sando M, Fawzi W. Factors associated with anemia among school-going adolescents aged 10-17 years in Zanzibar, Tanzania: a cross sectional study. BMC Public Health. 2023 Sep 18;23(1):1814. doi: 10.1186/s12889-023-16611-w.
- Derived from this study: PubMed 36792333Cliffer IR, Yussuf MH, Millogo O, Mwanyika-Sando M, Barry Y, Yusufu IS, Hemler EC, Sie A, Tinkasimile A, Compaore G, Ali AS, Kouanda I, Wang D, Mosha D, Fawzi W. Scaling-up high-impact micronutrient supplementation interventions to improve adolescents' nutrition and health in Burkina Faso and Tanzania: protocol for a cluster-randomised controlled trial. BMJ Open. 2023 Feb 15;13(2):e063686. doi: 10.1136/bmjopen-2022-063686.
- Individual participant dataSharing planned: No
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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.
Wafaie W Fawzi, MBBS, MPH, MS, DrPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron and folic acid (IFA) and Multiple Micronutrient Supplement (MMS) in people with Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
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 6 inclusion and 2 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 28 Feb 2024. 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 Tanzania. 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: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104554, which also lists 2 linked publications.
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 28 Feb 2024.