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Sponsors and Collaborators: |
Aga Khan University Civil Hospital, Hyderabad, Pakistan National Institute of Child Health, Karachi, Pakistan |
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Information provided by: | Aga Khan University |
ClinicalTrials.gov Identifier: | NCT00682955 |
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 |
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Incidence of Acute Diarrhea Incidence of Abdominal Pain |
Drug: Zinc Sulphate |
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 |
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 |
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B: Active Comparator
This group has been given Zinc Sulphate in Suspension Form.
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Drug: Zinc Sulphate
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
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A: Active Comparator
This group has been given Tablets of Zinc Sulphate.
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Drug: Zinc Sulphate
20 mg per day, Zinc Sulphate tablet has been given to subjects.
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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
Ages Eligible for Study: | 6 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pakistan, Sindh | |
Civil Hospital | |
Hyderabad, Sindh, Pakistan, 75300 | |
National Institute of Child Health | |
Karachi, Sindh, Pakistan, 75300 |
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 |
Diarrhea Zinc Sulphate Efficacy |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive Zinc Sulfate Abdominal Pain |
Zinc Trace Elements Pain Micronutrients |
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 |