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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

Study Record Versions

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12026-06-30Current
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Viewing V1 (2026-06-30)

Study Details

Study Identification

Unique Protocol IDBMU-PAED-2026-004
Brief TitleIron Supplementation in Adolescent Girls: a Cluster Trial
Official TitleWeekly Iron and Folic Acid Supplementation to Reduce Anaemia Among Adolescent Girls: a School-based Cluster Trial
Secondary IDs

Study Status

Record Verification2026-06
Overall StatusSuspended
Study Start2026-03-01
Primary Completion2026-11-30
Study Completion2027-01-31
First Submitted
First Submitted that Met QC Criteria2026-05-11
First Posted2026-05-11 [Actual]
Last Update Submitted that Met QC Criteria2026-06-30
Last Update Posted2026-06-30 [Actual]

Oversight

U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Product manufactured in and exported from the U.S.
Data MonitoringNo

Study Description

Brief SummaryThis school-based cluster trial evaluates weekly iron and folic acid supplementation to reduce anaemia among adolescent girls. Enrolment is temporarily paused.
Detailed DescriptionSchools 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.

Conditions

ConditionIron-deficiency Anaemia
Keywordsanaemia iron adolescents school health

Study Design

Study TypeInterventional
Primary PurposePrevention
Study Phase
Interventional Study ModelParallel Assignment
Number of Arms2
MaskingNone (Open Label)
AllocationRandomized
Enrollment3100 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
Experimental: Weekly supplementationDietary Supplement: Weekly iron and folic acid supplementation
No Intervention: Usual care

Outcome Measures

Primary Outcome MeasuresChange in mean haemoglobin concentration Time Frame: 6 months
Secondary Outcome MeasuresPrevalence of anaemia Time Frame: 6 months

Eligibility

Minimum Age10 Years
Maximum Age19 Years
Ages10 Years to 19 Years (Child, Adult)
SexFemale
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersYes
Criteria<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>

Contacts/Locations

Central Contact PersonDr Rumana Haque iron-adolescent@bmu.ac.bd
Study Officials
LocationCumilla, Chattogram, Bangladesh, 3500 Status: Suspended Facility: Cumilla Medical College

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents