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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 Overview

Brief Summary

This trial compares standard oral rehydration with an enhanced zinc-supplemented protocol on recovery time in young children with acute diarrhoea.

Detailed Description

Children presenting with acute diarrhoea are randomised to standard oral rehydration solution or oral rehydration with zinc supplementation. Time to resolution is the primary endpoint.

Official Title

A Post-marketing Trial of Zinc-supplemented Oral Rehydration Versus Standard Oral Rehydration in Acute Childhood Diarrhoea

Conditions

  • Acute Diarrhoea
  • Dehydration

Intervention/Treatment

  • Dietary Supplement: Oral rehydration solution with zinc
  • Drug: Standard oral rehydration solution

Other Study ID Numbers

BMU-PAED-2026-001

Study Start

2026-02-01

Primary Completion

2026-12-31

Study Completion

2027-02-28

Enrollment (Estimated)

900

Study Type

Interventional

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record.

This study has 1 location

Bangladesh

  • Khulna, Khulna, Bangladesh, 9000

    Active, not recruiting

    Khulna Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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>

Ages Eligible for Study

0 Years to 5 Years (Child)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel Assignment
Masking:
Double blind

Arms and Interventions

Participant Group/ArmIntervention/Treatment

Experimental: ORS plus zinc

Dietary Supplement: Oral rehydration solution with zinc

Active Comparator: Standard ORS

Drug: Standard oral rehydration solution

What is the study measuring?

Primary Outcome Measures

Outcome MeasureMeasure DescriptionTime Frame
Time to resolution of diarrhoeaUp to 7 days

Secondary Outcome Measures

Outcome MeasureMeasure DescriptionTime Frame
Hospital admission rateUp to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangladesh Medical University

Study Record Dates

These dates track the progress of study record and summary results submissions to the registry. Study records and reported results are reviewed by the Registry Office to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted that Met QC Criteria

2026-01-24

First Posted

2026-01-24

Study Record Updates

Last Update Submitted that Met QC Criteria

2026-09-02

Last Update Posted

2026-09-02

Last Verified

2026-08

More Information

Record History

Terms related to this study

Keywords Provided by Bangladesh Medical University

  • diarrhoea
  • oral rehydration
  • zinc
  • paediatrics

Plan for Individual Participant Data (IPD)

Plan to Share Individual Participant Data (IPD)?

Not provided

Drug and device information, study documents, and helpful links

Data Monitoring Committee

Yes
Oral Rehydration Plus Zinc for Acute Childhood Diarrhoea (BDCTR-2026-000112) | BMU Clinical Trial Registry