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Iron Supplementation in Adolescent Girls: a Cluster Trial
- BDCTR ID
- BDCTR-2026-000069
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Rumana Haque (Responsible Party)
- Last Update Posted
- 2026-06-30
Suspended
No longer looking for participants
Trial Contacts
| ContactsICMJE | Contact information is displayed when a study is open for participants to join. |
|---|
Study Record Dates
| First SubmittedICMJE | Not provided |
|---|---|
| First PostedICMJE | 2026-05-11 |
| Last Update Posted | 2026-06-30 |
| Last Verified* | 2026-06 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Change in mean haemoglobin concentration [Time Frame: 6 months] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Prevalence of anaemia [Time Frame: 6 months] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Iron Supplementation in Adolescent Girls: a Cluster Trial |
|---|---|
| Official Title*§ICMJE | Weekly Iron and Folic Acid Supplementation to Reduce Anaemia Among Adolescent Girls: a School-based Cluster Trial |
| Acronym[*] | Not provided |
| Brief Summary* | This school-based cluster trial evaluates weekly iron and folic acid supplementation to reduce anaemia among adolescent girls. Enrolment is temporarily paused. |
| Detailed Description | Schools are randomised to weekly supervised iron and folic acid supplementation or usual care. Haemoglobin is measured at six months. The study is currently suspended pending supply review. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | Not provided |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Condition*ICMJE | Iron-deficiency Anaemia |
| Keywords | anaemia iron adolescents school health |
| Intervention*ICMJE | Dietary Supplement: Weekly iron and folic acid supplementation |
| Study Arms*ICMJE | Experimental: Weekly supplementation Interventions: Dietary Supplement: Weekly iron and folic acid supplementation No Intervention: Usual care |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Suspended |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 3100 |
| Study Start Date*§ICMJE | 2026-03-01 |
| Primary Completion Date* | 2026-11-30 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2027-01-31 |
| Eligibility Criteria*ICMJE | <p>Inclusion Criteria:</p><ul><li>Adolescent girls aged 10 to 19 years enrolled in participating schools.</li></ul><p>Exclusion Criteria:</p><ul><li>Known haemoglobinopathy.</li></ul> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: Female |
| Ages*ICMJE | 10 Years to 19 Years (Child, Adult) |
| Accepts Healthy Volunteers*§ICMJE | Yes |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000069 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-PAED-2026-004 |
| Has Data Monitoring Committee | No |
| Studies a U.S. FDA-regulated Drug Product | Not provided |
| Studies a U.S. FDA-regulated Device Product | Not provided |
| Device Product Not Approved or Cleared by U.S. FDA | Not provided |
| Pediatric Postmarket Surveillance of a Device Product | Not provided |
| Product Manufactured in and Exported from the U.S. | Not provided |
| IPD Sharing StatementICMJE | Plan to Share IPD: Not provided |
| Current Responsible Party* | Dr Rumana Haque |
| Current Study Sponsor*ICMJE | Bangladesh Medical University |
| CollaboratorsICMJE | Not provided |
| InvestigatorsICMJE | Not provided |
| Registry Account | Imported legacy public registry |
Symbol Legend
- *
- Required
- *§
- Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
- [*]
- Conditionally required
- No Symbol
- Unmarked fields are optional. If no information is provided, fields will be labeled as “Not provided”.
- ICMJE
- Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP