Comparing the Efficacy of Different Zinc Formulations in the Treatment of Diarrhea (Zinc)

May 21, 2008 updated by: Aga Khan University

Comparing the Efficacy of Different Zinc Formulations in the Treatment of Acute Diarrhea Among Young Children at Hospital Based Setting in Pakistan

This project is aimed to evaluate the efficacy of two different zinc formulations (dispersible Zinc tablets versus Zinc suspension) for the treatment of acute diarrhea in hospital based settings. Additionally we intend to compare the effectiveness of treatments of different groups on the basis of usage of Zinc in the treatment of diarrhoea, and to monitor additional treatment components such as ORS, antibiotic usage rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be an open randomized trial in children designed to measure the impact and efficacy of daily zinc administration. There will be two groups in the study, one group will receive Zinc in the form tablets, other will receive in the form of suspension, both of these groups will also receive recommended treatment of diarrhea as per WHO protocol and these groups will be enrolled from the patients admitting in the Paediatric Unit of Civil Hospital, Hyderabad and NICH, Karachi with the complain of acute diarrhoea.

The intervention study will be undertaken in hospital based settings. A total recruitment of 300(150 each in each group) has been targetted during the study duration. The duration of this study shall be 9 months.

A brief history will be taken regarding the current illness and will be noted down in the specific forms. After the history the patient will be completely examined by the duty doctors, examination will emphasize of the vitals, status of dehydration and anthropometry. Patient will then be randomized in one of the groups and the procedure of using Zinc tablets or suspension will be explained to the mother or caretaker.The patient will be advised treatment according to the general condition and state of the dehydration and general health. All treatments will be noted down in the specific forms to have a record of what have been given to the patient and to keep the record of fluid intake. Stool samples for the detailed report and culture and sensitivity will be collected & sent to have the information regarding the status of stool and any isolated organism.

Follow-ups

  • The patients will be followed & examined thoroughly every 8 hourly till the time of discharge by a trained RMO.
  • At each follow up, details of illness characteristics, including the number and character of stools and vomiting, will be obtained.
  • Information regarding the associated symptoms including fever, abdominal pain distension and dysentery will be obtained. Hydration status, vitals and weight will also be assessed.
  • RMO will record about the proper dosages of zinc and confirm that weather or not patient is taking his medications during every follow up
  • RMO will also document the recovery of diarrhea in terms of reduction in frequency and duration of diarrhoea and all the information will be noted in the assigned follow up forms.
  • Any adverse effect of the associated with the Zinc will also be recorded.
  • Compliance will be measured by reported intake and by measuring the remaining volume of syrup in the returned bottles and number of tablets used in the blisters.
  • At the time of discharge a discharge summary form is also filled by RMO
  • The patients who will be discharged will be followed at home for a total of two weeks of illness.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Pakistan
    • Sindh
      • Hyderabad, Sindh, Pakistan, 75300
        • Civil Hospital
      • Karachi, Sindh, Pakistan, 75300
        • National Institute of Child Health

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

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 6 months to 5 years of age
  • Presented with passage of 3 or more loose or watery stools
  • Caretakers are willing to let their child to participate in the study.

Exclusion Criteria:

  • Failure to produce consent.
  • Children with severe malnutrition or having chronic illness

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
This group has been given Zinc Sulphate in Suspension Form.
Drug: Zinc Sulphate
20 mg per day, Zinc Sulphate tablet has been given to subjects.
Other Names:
  • Zincol
Drug: Zinc Sulphate
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
Other Names:
  • Zincat
Active Comparator: A
This group has been given Tablets of Zinc Sulphate.
Drug: Zinc Sulphate
20 mg per day, Zinc Sulphate tablet has been given to subjects.
Other Names:
  • Zincol
Drug: Zinc Sulphate
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
Other Names:
  • Zincat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of Efficacy of the two different Zinc Sulphate formulations
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of side effects of the two different Zinc Sulphate formulations used
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

Aga Khan University

Collaborators

National Institute of Child Health, Karachi, Pakistan
Civil Hospital, Hyderabad, Pakistan

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

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

May 23, 2008

Last Update Submitted That Met QC Criteria

May 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 857-PED/ERC-07

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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