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Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital No 1 Wroclaw.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital No 1 Wroclaw
ClinicalTrials.gov Identifier:
NCT01140074
First received: June 7, 2010
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  Purpose

Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.


Condition Intervention Phase
Acute Watery Diarrhoea
 Drug: Zinc Sulfate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by University Hospital No 1 Wroclaw:

Primary Outcome Measures:
  • Period of diarrhea in hours [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    The primary endpoint of our study is the time of acute diarrhea


Secondary Outcome Measures:
  • number of stools in consequent days [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    The secondary end points will be number of stools per day, necessity of hospitalization or not, tolerability and adherence to the therapy


Estimated Enrollment: 256
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc sulfate
Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics
 Drug: Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Other Name: brand product is not available in Poland
Placebo Comparator: Placebo
Children will be given placebo plus probiotics
 Drug: Zinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Other Name: brand product is not available in Poland

Detailed Description:

A double-blind, placebo controlled trial

- We are going to enroll 256 patients (aged > 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days.

Exclusion criteria:

severe dehydration (> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics

Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.

Randomization 1:1

  Eligibility

Ages Eligible for Study:   1 Month to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1-36 months
  • Acute diarrhea defined as 3 or more watery stools per day
  • Informed consent (parents)

Exclusion Criteria:

  • Severe dehydration (> 10%)
  • Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
  • Immune deficiency
  • Chronic digestive tract disease (e.g. celiac diseases, food allergy)
  • Antibiotic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140074

Contacts
Contact: Leszek Szenborn, Prof ++48717703151 szenborn@zak.am.wroc.pl
Contact: Ernest P. Kuchar, MD ++48717703156 kuchar@zak.am.wroc.pl

Locations
Poland
Szpital im Sw Jadwigi w Trzebicy Not yet recruiting
Trzebnica, Poland, 55-100
Contact: Jerzy Pejcz, MD     ++48713120913        
Principal Investigator: Jerzy Pejcz, MD            
Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu Not yet recruiting
Wroclaw, Poland, 50-345
Contact: Leszek Szenborn, Prof     ++48717703151     szenborn@zak.am.wroc.pl    
Contact: Ernest P. Kuchar, MD     ++48717703156     kuchar@zak.am.wroc.pl    
Principal Investigator: Leszek Szenborn, Prof            
Sponsors and Collaborators
University Hospital No 1 Wroclaw
Investigators
Principal Investigator: Leszek Szenborn, Prof Wroclaw Medical University
  More Information

Additional Information:
home page of department where study will be carried  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: prof Leszek Szenborn, Katedra i Klinka Pediatrii i Chorob Infekcyjnych AM we Wroclawiu
ClinicalTrials.gov Identifier: NCT01140074     History of Changes
Other Study ID Numbers: KB-501/2009
Study First Received: June 7, 2010
Last Updated: June 9, 2010
Health Authority: Poland: Ethics Committee

Keywords provided by University Hospital No 1 Wroclaw:
acute diarrhoea, children

Additional relevant MeSH terms:
Diarrhea
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 May 19, 2013