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Oral Rehydration Plus Zinc for Acute Childhood Diarrhoea

BDCTR ID
BDCTR-2026-000112
Sponsor
Bangladesh Medical University
Information provided by
Dr Tanvir Ahmed (Responsible Party)
Last Update Posted
2026-09-02

Active, not recruiting

No longer looking for participants

Study Record Versions

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Viewing V1 (2026-09-02)

Study Details

Study Identification

Unique Protocol IDBMU-PAED-2026-001
Brief TitleOral Rehydration Plus Zinc for Acute Childhood Diarrhoea
Official TitleA Post-marketing Trial of Zinc-supplemented Oral Rehydration Versus Standard Oral Rehydration in Acute Childhood Diarrhoea
Secondary IDs

Study Status

Record Verification2026-08
Overall StatusActive, not recruiting
Study Start2026-02-01
Primary Completion2026-12-31
Study Completion2027-02-28
First Submitted
First Submitted that Met QC Criteria2026-01-24
First Posted2026-01-24 [Actual]
Last Update Submitted that Met QC Criteria2026-09-02
Last Update Posted2026-09-02 [Actual]

Oversight

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

Study Description

Brief SummaryThis trial compares standard oral rehydration with an enhanced zinc-supplemented protocol on recovery time in young children with acute diarrhoea.
Detailed DescriptionChildren presenting with acute diarrhoea are randomised to standard oral rehydration solution or oral rehydration with zinc supplementation. Time to resolution is the primary endpoint.

Conditions

ConditionAcute Diarrhoea Dehydration
Keywordsdiarrhoea oral rehydration zinc paediatrics

Study Design

Study TypeInterventional
Primary PurposeTreatment
Study Phase
Interventional Study ModelParallel Assignment
Number of Arms2
MaskingDouble blind
AllocationRandomized
Enrollment900 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
Experimental: ORS plus zincDietary Supplement: Oral rehydration solution with zinc
Active Comparator: Standard ORSDrug: Standard oral rehydration solution

Outcome Measures

Primary Outcome MeasuresTime to resolution of diarrhoea Time Frame: Up to 7 days
Secondary Outcome MeasuresHospital admission rate Time Frame: Up to 7 days

Eligibility

Minimum Age0 Years
Maximum Age5 Years
Ages0 Years to 5 Years (Child)
SexAll
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersNo
Criteria<p>Inclusion Criteria:</p><ul><li>Children aged 6 months to 5 years with acute diarrhoea.</li></ul><p>Exclusion Criteria:</p><ul><li>Severe malnutrition requiring inpatient care.</li></ul>

Contacts/Locations

Central Contact PersonDr Tanvir Ahmed paeds-diarrhoea@bmu.ac.bd
Study Officials
LocationKhulna, Khulna, Bangladesh, 9000 Status: Active, not recruiting Facility: Khulna Medical College Hospital

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents