Zinc-ORS in Severe and Complicated Acute Diarrhea

This study has been completed.
Sponsor:
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by:
Centre For International Health
ClinicalTrials.gov Identifier:
NCT00370968
First received: August 31, 2006
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Diarrhea
Dehydration
Drug: Zinc sulphate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Extended Studies on Safety and Efficacy of Zinc-ORS Compared to ORS Alone in Hospitalized Children With Severe and Complicated Acute Diarrhea

Resource links provided by NLM:


Further study details as provided by Centre For International Health:

Primary Outcome Measures:
  • Stool output (g/kg/24h)
  • Duration of diarrhoea (days).

Estimated Enrollment: 352
Study Start Date: September 2003
Study Completion Date: December 2006
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. A recently completed trial at All India Institute Of Medical Sciences (AIIMS) measured the effect of zinc-ORS in the community, where most episodes are relatively mild. Zinc-ORS was efficacious in reducing the total number of stools (19% relative risk reduction, 95% CI 15% to 23%) and duration of diarrhoea (11% relative risk reduction, 95% CI 4% to 24%). In order to make policy decisions that standard ORS provided to children be fortified with zinc the national (and international) child health programs need a similar evidence base also for children hospitalized because of acute diarrhea. This is because these children represent the more severe end of the disease spectrum, i.e. they are the ones who are at the highest risk of dying.

The primary objective is to conduct a study of zinc-ORS in a hospital setting (i.e. of more severe diarrhea) to optimize and accurately measure the amount of zinc-ORS consumed and monitor stool output which is not possible in a field setting. The study will also examine the safety of using zinc-ORS; whether zinc-ORS affects the blood levels of sodium and potassium and of other micronutrients than zinc, such as copper and iron. The study will contribute to introducing a more efficacious ORS and help increase the ORS use rate which continues to be an important public health challenge in India.

The study will be carried out at two Clinical Research Facilities supervised by the Centre for Diarrhoeal Diseases and Nutrition Research, Division of Gastroenterology, Department of Pediatrics, AIIMS. 352 males aged 1-36 months with acute non-dysenteric diarrhoea and no systemic illness will be enrolled. Eligible children will be first 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. Minimum period of the study will be 48 hours and subjects will be discharged when diarrhoea has ceased or at 48 hours, whichever is later.

  Eligibility

Ages Eligible for Study:   1 Month to 36 Months
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370968

Locations
India
All India Institute of Medical Sciences
New Delhi, India, 110029
Deen Dayal Upadhyaya Hospital
New Delhi, India, 110064
Sponsors and Collaborators
Centre For International Health
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Shinjini Bhatnagar, PhD, MBBS All India Institute of Medical Sciences, New Delhi
Study Chair: Tor A Strand, MD, PhD Centre For International Health
Study Director: Halvor Sommerfelt, MD, PhD Centre For International Health
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370968     History of Changes
Other Study ID Numbers: IND-040 ICP (2001)/13
Study First Received: August 31, 2006
Last Updated: May 12, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Centre For International Health:
Children
India
Hospital
Zinc
Malnutrition
Treatment

Additional relevant MeSH terms:
Dehydration
Diarrhea
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014