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Zinc-ORS in Severe and Complicated Acute Diarrhea

NCT00370968 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2010-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Zinc sulphate

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Centre For International Health

    lead OTHER

Principal Investigators

  • Shinjini Bhatnagar, PhD, MBBS · All India Institute of Medical Sciences

  • Tor A Strand, MD, PhD · Centre For International Health

  • Halvor Sommerfelt, MD, PhD · Centre For International Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
36 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2006-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370968 on ClinicalTrials.gov