Zinc-ORS in Severe and Complicated Acute Diarrhea

NCT00370968 | Completed Phase 2

• 1 other identifier: IND-040 ICP (2001)/13
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 2

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.

Conditions

Diarrhea; Dehydration

Keywords

Children; India; Hospital; Zinc; Malnutrition; Treatment

Outcome Measures

Primary Outcomes (2)

• Stool output (g/kg/24h)

• Duration of diarrhoea (days).

Interventions

Zinc sulphate DRUG

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre For International Health: lead
• All India Institute of Medical Sciences: collaborator

Study Sites (2)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Deen Dayal Upadhyaya Hospital

New Delhi, 110064, India

Location

Related Publications (10)

• 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.

  PMID: 11986453 BACKGROUND

• 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.

  PMID: 12198006 BACKGROUND

• 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.

  PMID: 11509104 BACKGROUND

• Fontaine O. Effect of zinc supplementation on clinical course of acute diarrhoea. J Health Popul Nutr. 2001 Dec;19(4):339-46.

  PMID: 11855358 BACKGROUND

• 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.

  PMID: 16155274 BACKGROUND

• 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.

  PMID: 12410197 BACKGROUND

• 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.

  PMID: 12424162 BACKGROUND

• 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.

  PMID: 12042580 BACKGROUND

• 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.

  PMID: 7651474 BACKGROUND

• 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.

  PMID: 21788757 DERIVED

MeSH Terms

Conditions

Diarrhea; Dehydration; Malnutrition

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Shinjini Bhatnagar, PhD, MBBS

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Tor A Strand, MD, PhD

  Centre For International Health

  STUDY CHAIR

• Halvor Sommerfelt, MD, PhD

  Centre For International Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 1, 2006
• Study Start: September 1, 2003
• Study Completion: December 1, 2006
• Last Updated: May 13, 2010

Record last verified: 2010-05

Locations

IN (2)