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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
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 | 2026-01-24 |
| Last Update Posted | 2026-09-02 |
| Last Verified* | 2026-08 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Time to resolution of diarrhoea [Time Frame: Up to 7 days] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Hospital admission rate [Time Frame: Up to 7 days] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Oral Rehydration Plus Zinc for Acute Childhood Diarrhoea |
|---|---|
| Official Title*§ICMJE | A Post-marketing Trial of Zinc-supplemented Oral Rehydration Versus Standard Oral Rehydration in Acute Childhood Diarrhoea |
| Acronym[*] | Not provided |
| 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. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | Not provided |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: Double blind Primary Purpose: Treatment |
| Condition*ICMJE | Acute Diarrhoea Dehydration |
| Keywords | diarrhoea oral rehydration zinc paediatrics |
| Intervention*ICMJE | Dietary Supplement: Oral rehydration solution with zinc Drug: Standard oral rehydration solution |
| Study Arms*ICMJE | Experimental: ORS plus zinc Interventions: Dietary Supplement: Oral rehydration solution with zinc Active Comparator: Standard ORS Interventions: Drug: Standard oral rehydration solution |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Active, not recruiting |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 900 |
| Study Start Date*§ICMJE | 2026-02-01 |
| Primary Completion Date* | 2026-12-31 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2027-02-28 |
| Eligibility Criteria*ICMJE | <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> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: All |
| Ages*ICMJE | 0 Years to 5 Years (Child) |
| Accepts Healthy Volunteers*§ICMJE | No |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000112 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-PAED-2026-001 |
| Has Data Monitoring Committee | Yes |
| 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 Tanvir Ahmed |
| 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