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

June 9, 2010 updated by: University Hospital No 1 Wroclaw

Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Trzebnica, Poland, 55-100
        • Szpital im Sw Jadwigi w Trzebicy
        • Contact:
          • Jerzy Pejcz, MD
          • Phone Number: ++48713120913
        • Principal Investigator:
          • Jerzy Pejcz, MD
      • Wroclaw, Poland, 50-345
        • Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leszek Szenborn, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • brand product is not available in Poland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Period of diarrhea in hours
Time Frame: 15 days
The primary endpoint of our study is the time of acute diarrhea
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of stools in consequent days
Time Frame: 15 days
The secondary end points will be number of stools per day, necessity of hospitalization or not, tolerability and adherence to the therapy
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital No 1 Wroclaw

Investigators

  • Principal Investigator: Leszek Szenborn, Prof, Wroclaw Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 10, 2010

Last Update Submitted That Met QC Criteria

June 9, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB-501/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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