Zinc-ORS in Severe and Complicated Acute Diarrhea

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

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 age (1up to 5 months, 6-35 months). Within the two age strata the patients will be randomized to receive zinc-ORS (fortified with 40 mg elemental zinc as zinc gluconate per litre) or standard WHO ORS. The major outcome measures will be stool output and duration of diarrhea. The safety of administering zinc will be determined by examining the effect of zinc ingestion on vomiting, sodium and potassium homeostasis, plasma zinc and copper, and iron stores and concentration of serum transferrin receptor.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre For International Health
• Collaborator: All India Institute of Medical Sciences, New Delhi
• Treatments: Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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