Comparing the Efficacy of Different Zinc Formulations in the Treatment of Diarrhea - Full Text View

Sponsors and Collaborators:	Aga Khan University Civil Hospital, Hyderabad, Pakistan National Institute of Child Health, Karachi, Pakistan
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00682955

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

MedlinePlus related topics: Abdominal Pain Diarrhea

Drug Information available for: Zinc sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Comparing the Efficacy of Different Zinc Formulations in the Treatment of Acute Diarrhea Among Young Children at Hospital Based Setting in Pakistan

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
B: Active Comparator 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.
A: Active Comparator This group has been given Tablets of Zinc Sulphate.	Drug: Zinc Sulphate 20 mg per day, Zinc Sulphate tablet has been given to subjects.

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

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

Locations

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

Keywords provided by Aga Khan University:

Diarrhea
Zinc Sulphate
Efficacy

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Zinc Sulfate
Abdominal Pain

Zinc
Trace Elements
Pain
Micronutrients

Additional relevant MeSH terms:

Diarrhea
Signs and Symptoms, Digestive
Abdominal Pain
Growth Substances
Physiological Effects of Drugs
Pain
Trace Elements
Pharmacologic Actions

Signs and Symptoms
Zinc Sulfate
Therapeutic Uses
Zinc
Astringents
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009