DiarrheaPhase 4NCT00942812
Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
A Phase 4 study testing Diarrhea Pack and ORS in people with Diarrhea, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for 2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per the World Health Organization (WHO) guidelines brings about a considerable decline in the burden of the disease but there is still a… Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- Diarrhea Pack and ORS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2009to Sep 2010
- Phase
- Phase 4
- 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 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate
Who cannot join
- Failure to provide consent or children having debilitating illness or requiring emergency hospital care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack(Comprising of Low Osmolality ORS, Zinc Tablets, Water Purification Tablets and Pictorial Chart) on Childhood Diarrhea.
Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for 2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per the World Health Organization (WHO) guidelines brings about a considerable decline in the burden of the disease but there is still a lot to be done for this issue. Zinc supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk of developing infectious diseases which eventually lead to a high burden of mortality.
In order to prevent and effectively manage diarrheal episodes, it is important that water purification tablets, zinc and oral rehydration salt is always available in each household. Though, these products are easily available in the market separately, but are rarely available together in any household. If these products are made available in a single packet, it is likely to be an effective strategy in combating diarrheal diseases in the community.
- Conditions
- Diarrhea
- Being tested
- Diarrhea Pack, ORS
- Keywords
- Children, Recovery, Diarrhea Pack, Social Marketing
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diarrhea PackOther
Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart
ORSOther
ORS has been supplied to diarrheal cases as standard care through the LHW program at community level
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart. Receives: Other: Diarrhea Pack |
| Control | Other | Standard Care through National LHW (Lady Health Workers)program Receives: Other: ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Diarrhea related morbidity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942812
- Sponsor's protocol ID
- 1235-Ped/ERC-09
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack(Comprising of Low Osmolality ORS, Zinc Tablets, Water Purification Tablets and Pictorial Chart) on Childhood Diarrhea.
- ClinicalTrials.gov ID
- NCT00942812
- Acronym / sponsor ID
- 1235-Ped/ERC-09
- Conditions
- Diarrhea
- Keywords
- Children, Recovery, Diarrhea Pack, Social Marketing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,200 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- John Snow, Inc.
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Jul 2009 (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.
Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for 2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per the World Health Organization (WHO) guidelines brings about a considerable decline in the burden of the disease but there is still a lot to be done for this issue. Zinc supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk of developing infectious diseases which eventually lead to a high burden of mortality.
In order to prevent and effectively manage diarrheal episodes, it is important that water purification tablets, zinc and oral rehydration salt is always available in each household. Though, these products are easily available in the market separately, but are rarely available together in any household. If these products are made available in a single packet, it is likely to be an effective strategy in combating diarrheal diseases in the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Diarrhea PackA diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart. |
| Control | Other | Other: ORSStandard Care through National LHW (Lady Health Workers)program |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate
Key exclusion criteria (1 listed)
- Failure to provide consent or children having debilitating illness or requiring emergency hospital care.
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 |
|---|---|---|
| Diarrhea PackLow osmolality ORS, Zinc tablets, water purification tablets and pictorial chart | Other | Intervention |
| ORSORS has been supplied to diarrheal cases as standard care through the LHW program at community level | Other | Control |
Primary outcome
Reduction in Diarrhea related morbidity
Time frame: 1 year
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 10 Aug 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diarrhea Pack and ORS in people with Diarrhea, run by Aga Khan University at 1 site 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 1 inclusion and 1 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 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in Diarrhea related morbidity (time frame: 1 year). 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 10 Aug 2011.