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

This study has been completed.
Sponsor:
Collaborators:
Civil Hospital, Hyderabad, Pakistan
National Institute of Child Health, Karachi, Pakistan
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00682955
First received: May 20, 2008
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Incidence of Acute Diarrhea
Incidence of Abdominal Pain
Drug: Zinc Sulphate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Different Zinc Formulations in the Treatment of Acute Diarrhea Among Young Children at Hospital Based Setting in Pakistan

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Comparison of Efficacy of the two different Zinc Sulphate formulations [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of side effects of the two different Zinc Sulphate formulations used [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B
This group has been given Zinc Sulphate in Suspension Form.
Drug: Zinc Sulphate
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
Other Name: 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 Name: Zincol

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.
  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682955

Locations
Pakistan
Civil Hospital
Hyderabad, Sindh, Pakistan, 75300
National Institute of Child Health
Karachi, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
Civil Hospital, Hyderabad, Pakistan
National Institute of Child Health, Karachi, Pakistan
  More Information

No publications provided

Responsible Party: Dr Zulfiqar A Bhutta, The Aga Khan University
ClinicalTrials.gov Identifier: NCT00682955     History of Changes
Other Study ID Numbers: 857-PED/ERC-07
Study First Received: May 20, 2008
Last Updated: May 21, 2008
Health Authority: Pakistan: The Aga Khan University

Keywords provided by Aga Khan University:
Diarrhea
Zinc Sulphate
Efficacy

Additional relevant MeSH terms:
Abdominal Pain
Diarrhea
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Zinc
Zinc Sulfate
Astringents
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 27, 2014