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Zinc-ORS in Severe and Complicated Acute Diarrhea

Primary Purpose

Diarrhea, Dehydration

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Zinc sulphate
Sponsored by
Centre For International Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Children, India, Hospital, Zinc, Malnutrition, Treatment

Eligibility Criteria

1 Month - 36 Months (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences
  • Deen Dayal Upadhyaya Hospital

Outcomes

Primary Outcome Measures

Stool output (g/kg/24h)
Duration of diarrhoea (days).

Secondary Outcome Measures

Full Information

First Posted
August 31, 2006
Last Updated
May 12, 2010
Sponsor
Centre For International Health
Collaborators
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT00370968
Brief Title
Zinc-ORS in Severe and Complicated Acute Diarrhea
Official Title
Extended Studies on Safety and Efficacy of Zinc-ORS Compared to ORS Alone in Hospitalized Children With Severe and Complicated Acute Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre For International Health
Collaborators
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Dehydration
Keywords
Children, India, Hospital, Zinc, Malnutrition, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
352 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zinc sulphate
Primary Outcome Measure Information:
Title
Stool output (g/kg/24h)
Title
Duration of diarrhoea (days).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinjini Bhatnagar, PhD, MBBS
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tor A Strand, MD, PhD
Organizational Affiliation
Centre For International Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Halvor Sommerfelt, MD, PhD
Organizational Affiliation
Centre For International Health
Official's Role
Study Director
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Deen Dayal Upadhyaya Hospital
City
New Delhi
ZIP/Postal Code
110064
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
11986453
Citation
Strand TA, Chandyo RK, Bahl R, Sharma PR, Adhikari RK, Bhandari N, Ulvik RJ, Molbak K, Bhan MK, Sommerfelt H. Effectiveness and efficacy of zinc for the treatment of acute diarrhea in young children. Pediatrics. 2002 May;109(5):898-903. doi: 10.1542/peds.109.5.898.
Results Reference
background
PubMed Identifier
12198006
Citation
Mahalanabis D, Chowdhury A, Jana S, Bhattacharya MK, Chakrabarti MK, Wahed MA, Khaled MA. Zinc supplementation as adjunct therapy in children with measles accompanied by pneumonia: a double-blind, randomized controlled trial. Am J Clin Nutr. 2002 Sep;76(3):604-7. doi: 10.1093/ajcn/76.3.604.
Results Reference
background
PubMed Identifier
11509104
Citation
Mahalanabis D, Bhan MK. Micronutrients as adjunct therapy of acute illness in children: impact on the episode outcome and policy implications of current findings. Br J Nutr. 2001 May;85 Suppl 2:S151-8. doi: 10.1079/bjn2000308.
Results Reference
background
PubMed Identifier
11855358
Citation
Fontaine O. Effect of zinc supplementation on clinical course of acute diarrhoea. J Health Popul Nutr. 2001 Dec;19(4):339-46.
Results Reference
background
PubMed Identifier
16155274
Citation
Brooks WA, Santosham M, Roy SK, Faruque AS, Wahed MA, Nahar K, Khan AI, Khan AF, Fuchs GJ, Black RE. Efficacy of zinc in young infants with acute watery diarrhea. Am J Clin Nutr. 2005 Sep;82(3):605-10. doi: 10.1093/ajcn.82.3.605.
Results Reference
background
PubMed Identifier
12410197
Citation
Bahl R, Bhandari N, Saksena M, Strand T, Kumar GT, Bhan MK, Sommerfelt H. Efficacy of zinc-fortified oral rehydration solution in 6- to 35-month-old children with acute diarrhea. J Pediatr. 2002 Nov;141(5):677-82. doi: 10.1067/mpd.2002.128543.
Results Reference
background
PubMed Identifier
12424162
Citation
Baqui AH, Black RE, El Arifeen S, Yunus M, Chakraborty J, Ahmed S, Vaughan JP. Effect of zinc supplementation started during diarrhoea on morbidity and mortality in Bangladeshi children: community randomised trial. BMJ. 2002 Nov 9;325(7372):1059. doi: 10.1136/bmj.325.7372.1059.
Results Reference
background
PubMed Identifier
12042580
Citation
Bhandari N, Bahl R, Taneja S, Strand T, Molbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Substantial reduction in severe diarrheal morbidity by daily zinc supplementation in young north Indian children. Pediatrics. 2002 Jun;109(6):e86. doi: 10.1542/peds.109.6.e86.
Results Reference
background
PubMed Identifier
7651474
Citation
Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha A, Jalla S. Zinc supplementation in young children with acute diarrhea in India. N Engl J Med. 1995 Sep 28;333(13):839-44. doi: 10.1056/NEJM199509283331304.
Results Reference
background
PubMed Identifier
21788757
Citation
Wadhwa N, Natchu UC, Sommerfelt H, Strand TA, Kapoor V, Saini S, Kainth US, Bhatnagar S. ORS containing zinc does not reduce duration or stool volume of acute diarrhea in hospitalized children. J Pediatr Gastroenterol Nutr. 2011 Aug;53(2):161-7. doi: 10.1097/MPG.0b013e318213ca55.
Results Reference
derived

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Zinc-ORS in Severe and Complicated Acute Diarrhea

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