Acute DiarrhoeaPhase 1NCT01376440
Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children
A Phase 1 study testing household water treatment in people with Acute Diarrhoea, run by Haramaya Unversity at 1 site in Ethiopia.
Trial summary
The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Acute Diarrhoea
- What is being tested?
- household water treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 845 participants
- Where
- 1 siteEthiopia
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 1
- 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 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children under five years of age in the randomly selected clusters of Kersa district
Who cannot join
- seriously sick children in the randomly selected clusters of Kersa district
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Effectiveness of Household Water Chlorination in Reducing the Prevalence of Diarrhea Among Under Five Children in Eastern Ethiopia
The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Source protection is considered the main intervention area to achieve this goal. However, research worldwide that has shown that even drinking water which is safe at the source is subject to frequent and extensive fecal contamination during collection, storage and use in the home. This contamination is through the introduction of cups, dippers or hands, contamination by flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can pose infectious disease risks if they become contaminated due to unsanitary collection, storage conditions and practices within households.
To reduce this problem, point-of-use water treatment has been advocated as a means to substantially decrease the global burden of diarrhea and to contribute to the MDGs. However, research indicates that there are many unanswered questions around Household water treatment (HWT) that require small or medium scale epidemiological studies and randomized controlled trials, especially with regard to effectiveness, acceptability and identifying suitable target populations. Some of the most urgent questions to be resolved are:(1) How much of the currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted? (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease is high.
hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive children? hypothesis: Do household water treatment with chlorine acceptable in the community?
- Conditions
- Acute Diarrhoea
- Being tested
- household water treatment
- Keywords
- three or more loss stools in 24 hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
household water treatmentOther
Also called 1.25% sodium hypochlorite
household water treatment with 1.25% sodium hypochlorite
| Study group | Role | What they receive |
|---|---|---|
| Household water treatment | Experimental | household water treatment with 1.25% sodium hypochlorite Receives: Other: household water treatment |
| control | No intervention | Usual practice (the use of "Jerrican" for water storage, which is considered as safe storage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of diarrhea among under five children
weekly visit of the household for the presence of diarrhoea among underfive for four months in both the intervention and control groups
Measured: four months
Secondary outcomes (2)
To assess the weight gain among the intervention and control groups of under five children
This is designed to assess whether there is weight gain (objective outcome) in children assigned to the intervention group compared to the control group. It is supplement to the prevalence of diarrhea which is subjective outcome for this study
Measured: At the beginning and end of the study ( 4 months interval)
Residual chlorine test
The use of the intervention (1.25% hypochlorite) is confirmed by the testing the residual chlorine weekly for for months from each household assigned in the intrevention group
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiarrhoeaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haramaya Unversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bezatu Mengiste, Haramaya Unversity
- Investigators
- Bezatu M Alemu, M.Sc, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376440
- Sponsor's protocol ID
- SGS13/15/11
- Status last verified
- Jan 2012
- First submitted
- 16 Jun 2011
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mengistie B, Berhane Y, Worku A. Household water chlorination reduces incidence of diarrhea among under-five children in rural Ethiopia: a cluster randomized controlled trial. PLoS One. 2013 Oct 23;8(10):e77887. doi: 10.1371/journal.pone.0077887. eCollection 2013.
PubMed 24194899
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Effectiveness of Household Water Chlorination in Reducing the Prevalence of Diarrhea Among Under Five Children in Eastern Ethiopia
- ClinicalTrials.gov ID
- NCT01376440
- Acronym / sponsor ID
- SGS13/15/11
- Conditions
- Acute Diarrhoea
- Keywords
- three or more loss stools in 24 hours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 845 participants (actual)
- Lead sponsor
- Haramaya UnversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Jun 2011 (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.
The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Source protection is considered the main intervention area to achieve this goal. However, research worldwide that has shown that even drinking water which is safe at the source is subject to frequent and extensive fecal contamination during collection, storage and use in the home. This contamination is through the introduction of cups, dippers or hands, contamination by flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can pose infectious disease risks if they become contaminated due to unsanitary collection, storage conditions and practices within households.
To reduce this problem, point-of-use water treatment has been advocated as a means to substantially decrease the global burden of diarrhea and to contribute to the MDGs. However, research indicates that there are many unanswered questions around Household water treatment (HWT) that require small or medium scale epidemiological studies and randomized controlled trials, especially with regard to effectiveness, acceptability and identifying suitable target populations. Some of the most urgent questions to be resolved are:(1) How much of the currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted? (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease is high.
hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive children? hypothesis: Do household water treatment with chlorine acceptable in the community?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Household water treatment | Experimental | Other: household water treatmenthousehold water treatment with 1.25% sodium hypochlorite |
| control | No intervention | –Usual practice (the use of "Jerrican" for water storage, which is considered as safe storage) |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children under five years of age in the randomly selected clusters of Kersa district
Key exclusion criteria (1 listed)
- seriously sick children in the randomly selected clusters of Kersa district
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 |
|---|---|---|
| household water treatmentAlso: 1.25% sodium hypochloritehousehold water treatment with 1.25% sodium hypochlorite | Other | Household water treatment |
Primary outcome
To assess the prevalence of diarrhea among under five children
Time frame: four months
weekly visit of the household for the presence of diarrhoea among underfive for four months in both the intervention and control groups
2 secondary outcomes
To assess the weight gain among the intervention and control groups of under five children
Time frame: At the beginning and end of the study ( 4 months interval)
Residual chlorine test
Time frame: four 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 24 Jan 2012.
- Derived from this study: PubMed 24194899Mengistie B, Berhane Y, Worku A. Household water chlorination reduces incidence of diarrhea among under-five children in rural Ethiopia: a cluster randomized controlled trial. PLoS One. 2013 Oct 23;8(10):e77887. doi: 10.1371/journal.pone.0077887. eCollection 2013.
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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.
Bezatu M Alemu, M.Sc principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing household water treatment in people with Acute Diarrhoea, run by Haramaya Unversity at 1 site in Ethiopia.
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 24 Jan 2012. 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 Ethiopia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the prevalence of diarrhea among under five children (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376440, which also lists 1 linked publication.
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 24 Jan 2012.