Incidence of Acute DiarrheaZincNCT00682955
Comparing the Efficacy of Different Zinc Formulations in the Treatment of Diarrhea
A study testing Zinc Sulphate in people with Incidence of Acute Diarrhea and Incidence of Abdominal Pain, run by Aga Khan University at 2 sites in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Incidence of Acute Diarrhea, Incidence of Abdominal Pain
- What is being tested?
- Zinc Sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesPakistan
- Study dates
- Aug 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Failure to produce consent.
- Children with severe malnutrition or having chronic illness
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Civil Hospital
Hyderābād, Sindh, 75300
National Institute of Child Health
Karachi, Sindh, 75300
About this 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
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.
Read the 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.
- Being tested
- Zinc Sulphate
- Keywords
- Diarrhea, Zinc Sulphate, Efficacy
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulphateDrug
Also called Zincol
20 mg per day, Zinc Sulphate tablet has been given to subjects.
Zinc SulphateDrug
Also called Zincat
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | This group has been given Zinc Sulphate in Suspension Form. Receives: Drug: Zinc Sulphate |
| A | Active comparator | This group has been given Tablets of Zinc Sulphate. Receives: Drug: Zinc Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Efficacy of the two different Zinc Sulphate formulations
Measured: 9 months
Secondary outcomes (1)
Comparison of side effects of the two different Zinc Sulphate formulations used
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Acute DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Civil Hospital, Hyderabad, Pakistan, National Institute of Child Health, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682955
- Sponsor's protocol ID
- 857-PED/ERC-07
- Acronym
- Zinc
- Status last verified
- May 2008
- First submitted
- 20 May 2008
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Different Zinc Formulations in the Treatment of Acute Diarrhea Among Young Children at Hospital Based Setting in Pakistan
- ClinicalTrials.gov ID
- NCT00682955
- Acronym / sponsor ID
- Zinc / 857-PED/ERC-07
- Keywords
- Diarrhea, Zinc Sulphate, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Civil Hospital, Hyderabad, Pakistan, National Institute of Child Health, Karachi, Pakistan
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: Zinc SulphateThis group has been given Zinc Sulphate in Suspension Form. |
| A | Active comparator | Drug: Zinc SulphateThis group has been given Tablets of Zinc Sulphate. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to produce consent.
- Children with severe malnutrition or having chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc SulphateAlso: Zincol20 mg per day, Zinc Sulphate tablet has been given to subjects. | Drug | A |
| Zinc SulphateAlso: Zincat20 mg per day of Zinc Sulphate in suspension form has been given to subjects. | Drug | B |
Primary outcome
Comparison of Efficacy of the two different Zinc Sulphate formulations
Time frame: 9 months
1 secondary outcome
Comparison of side effects of the two different Zinc Sulphate formulations used
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Sulphate in people with Incidence of Acute Diarrhea and Incidence of Abdominal Pain, run by Aga Khan University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Efficacy of the two different Zinc Sulphate formulations (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2008.