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Novel dose of zinc therapy in childhood diarrhoea: Standard dose vs Low dose

Comparative efficacy of 10 mg zinc supplement versus 20 mg standard supplement in treatment of acute diarrhoea in children: A randomized control trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057259
Enrollment
200
Registered
2023-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified

Interventions

Intervention1: 10mg zinc supplement: 10 mg zinc supplement in 100 children with acute diarrhea,for 14 days Control Intervention1: 20 mg standard zinc supplement: 20mg zinc in 100 children with acute d

Sponsors

Tanisha Negi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 6 months to 59 months of age ; Presenting with acute diarrhea / dysentry (as per WHO criteria) not longer that 72 hours /3 days before the presentation.

Exclusion criteria

Exclusion criteria: 1. Children identified as SAM as per WHO criteria.18 2. Children undergoing treatment for severe dehydration. 3. Have been treated for measles within past 1 month. 4. Diagnosed cases of severe pneumonia, sepsis and malaria. 5. Known cases of chronic systemic disorders. 6. Has already received zinc supplements in the preceding 3 days before enrolment. 7. Known sensitivity to zinc containing compounds.

Design outcomes

Primary

MeasureTime frame
Efficacy of treatment in both the groups will be compared on following parameters: 1.Proportion of children with total number of loose or watery stools, (Mean + SD) non inferiority margin mean difference of +0.3 stools 2.Percentage of subjects with diarrhoea for more than 5 days with non inferiority margin of 1.1%. Timepoint: 14 days

Secondary

MeasureTime frame
Both the groups will be compared on following parameters: 1. Proportion of subjects having vomiting & other adverse events in each arm of the study population. 2. Proportions of subjects progressing to persistent diarrhoea. 3. Proportion of Moderately Acute Malnourished children (MAM) in both the research arms compared for the efficacy of treatment as defined in primary outcome parameters. Timepoint: 14 days

Countries

India

Contacts

Public ContactTanisha Negi

Lady hardinge medical College Delhi

srikantabasu@gmail.com9818291595

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026