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ORAL ZINC SUPPLEMENTATION FOR ACUTE DIARRHEA IN CHILDREN OLDER THAN 5 YEARS

Phase 3
Completed
Conditions
Health Condition 1: null- Acute dehydrating diarrhoea in children more than 5 years ageHealth Condition 2: A09- Infectious gastroenteritis and colitis, unspecified
Registration Number
CTRI/2011/06/001807
Lead Sponsor
Intramural research grant University College of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
134
Inclusion Criteria

Children aged 5-12 years presenting to pediatric casualty with acute watery diarrhea (3 or more episodes of loose stools over previous 24 h) of less than 72 hours duration, with some or severe dehydration will be included as the study population.

Exclusion Criteria

1)Dysentery (blood in stools)

2)Coexisting severe systemic illness

3)Received any zinc containing multivitamin / mineral supplementation for 7 days in last 3 months

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Duration of diarrheaTimepoint: Duration of diarrhea defined as the time for clinical resolution of diarrhea.
Secondary Outcome Measures
NameTimeMethod
1.Number of days with watery stools <br/ ><br>2.Clinical recovery <br/ ><br>3.Amount of fluids needed <br/ ><br>4.Time taken for rehydration <br/ ><br>5.Recurrence in next 3 monthsTimepoint: 1.Number of days with watery stools: A day with watery stools will be defined as the passage of three or more watery stools in 24 hrs <br/ ><br>2.Clinical recovery: defined as resolution of diarrhea within 72 hours after the start of therapy. <br/ ><br>3.Amount of fluids needed (ORS or intravenous fluids) <br/ ><br>4.Time taken for rehydration: from enrolment to complete rehydration (hydration retained for at least 24 hours) <br/ ><br>5.Recurrence in next 3 months: number of episodes of acute diarrhea <br/ ><br>
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