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A study in children aged 6 months to 5 years with diarrhea comparing two doses of zinc (10 mg and 20 mg) for recovery time and vomiting

A randomized, open-label, parallel-group non-inferiority trial comparing low-dose zinc (10 mg/day) versus standard-dose zinc (20 mg/day) in children aged 6 59 months with acute diarrhea - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/109899
Enrollment
420
Registered
2026-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Low-dose zinc supplementation: Elemental zinc 10 mg orally once daily for 14 days, started at enrollment, along with standard WHO-recommended management including oral rehydration solut

Sponsors

PSG Institute of Medical Sciences and Reaseach
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: More than or equal to 3 loose or watery stools per day Duration less than 14 days Caregiver consent

Exclusion criteria

Exclusion criteria: Persistent diarrhea ( Greater than 14 days) Severe acute malnutrition Severe dehydration requiring IV fluids Dysentery (blood in stool) Zinc supplementation within last 1 month Known chronic illness

Design outcomes

Primary

MeasureTime frame
Duration of diarrhea (in days) from randomization to cessation of diarrheaTimepoint: Telephonic assessment on Day 1 , Day 3 ,Day 7 and Day 14

Secondary

MeasureTime frame
Number of loose stools in the first 72 hours . Timepoint: Telephonic assessment on Day 1 and Day 3;Proportion of vomiting within 30 minutes of taking zinc in each group Timepoint: Telephonic assessment on Day 1 , Day 3 ,Day 7 and Day 14

Countries

India

Contacts

Public ContactKeerthi Senthilkumaran

PSG Institute of Medical Sciences and Research

keersen20@gmail.com7539960226

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026