Status:
COMPLETED
Zinc-ORS in Severe and Complicated Acute Diarrhea
Lead Sponsor:
Centre For International Health
Collaborating Sponsors:
All India Institute of Medical Sciences
Conditions:
Diarrhea
Dehydration
Eligibility:
MALE
1-36 years
Phase:
PHASE2
PHASE3
Brief Summary
Three-hundred-and-fifty-two males aged 1-36 months with acute non-dysenteric diarrhoea and no systemic illness will be enrolled in this clinical trial. Eligible children will be stratified by their ag...
Detailed Description
Zinc deficiency is prevalent in developing countries due to inadequate food intake, low intake of foods from animal sources and high dietary intake of phytate, a substance that reduces zinc absorption...
Eligibility Criteria
Inclusion
- Males
- Age 1 month up to 36 months:
- Passage of 3 or more liquid stools in a 24-hour period, every day, and at least one in 12 hours prior to admission
- Diarrhea for \< 7days (168 hours)
Exclusion
- severe systemic illness requiring intensive care management; systemic infection will be suspected if there is a general appearance of non-wellbeing with one or more of the following symptoms: shrill cry and irritability, temperature instability, hypotension, hypoglycemia, altered sensorium, lethargy or refusal of feeds, abdominal distension.
- chronic illness like Tuberculosis, Nephrotic syndrome, malignancy etc or any surgical disorder.
- severe malnutrition (weight for age \<65% of NCHS median
- gross blood in stool
- refusal of consent
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00370968
Start Date
September 1 2003
End Date
December 1 2006
Last Update
May 13 2010
Active Locations (2)
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1
All India Institute of Medical Sciences
New Delhi, India, 110029
2
Deen Dayal Upadhyaya Hospital
New Delhi, India, 110064