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
Details
Lead Sponsor:
Centre For International Health
Collaborator:
All India Institute of Medical Sciences, New Delhi