DiarrhoeaPhase 3NCT01202383
Double-blinded Trial of Household-based Chlorination in India
A Phase 3 study testing Household-based water treatment with NADCC tablets in people with Diarrhoea, run by London School of Hygiene and Tropical Medicine at 1 site in India.
Trial summary
The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Household-based water treatment with NADCC tablets
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,163 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Households with at least one child< 5
- Male and female head of household consent to participate
- Reside permanently in study area
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets
The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. For more than a century, chlorine has be used to treat water in municipal systems in developed countries. Lack of infrastructure has prevented its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for more than 30 years in emergencies and has recently been approved for routine treatment of drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of the food-grade ingredients in the effective tablet, without the chlorine. Study participants will be supplied with tablets (intervention or placebo) and instructed to use the same to treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and weight-for-age Z scores in <5s. Chlorine residual and bacteriological quality of water stored in the home will be measured each month. The study will also assess the impact of the intervention on absenteeism from school and work and on health care expenditure for diarrhoea.
- Conditions
- Diarrhoea
- Being tested
- Household-based water treatment with NADCC tablets, Household-based water treatment with placebo tablets
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Household-based water treatment with NADCC tabletsBehavioural
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
Household-based water treatment with placebo tabletsBehavioural
Study participants will be supplied with tablets and encouraged to use them for treating their water daily
| Study group | Role | What they receive |
|---|---|---|
| NADCC tablets | Active comparator | Not described Receives: Behavioral: Household-based water treatment with NADCC tablets |
| Placebo tablets | Placebo comparator | Not described Receives: Behavioral: Household-based water treatment with placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
diarrhoea morbidity
diarrhoea will be recorded among <5s and all ages
Measured: monthly visits for 12 months
Secondary outcomes (5)
weight for age Z-score
weight will be measured among <5s
Measured: monthly visits for 12 months
bacteriological water quality in household storage container
Measured: monthly visits for 12 months
residual chlorine in household storage container
Measured: monthly visits for 12 months
absenteeism from school and work
Measured: monthly visits over 12 months
health care expenditure for diarrhea
Measured: One time visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Population Services International, Partners for Affordable Technologies in Health, United States Agency for International Development (USAID), Chemical Council of America, Medentech, Indian Institute of Health Management Research
- Responsible party
- Principal investigator, Thomas Clasen, London School of Hygiene and Tropical Medicine
- Investigators
- Thomas Clasen, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202383
- Sponsor's protocol ID
- EH224
- Status last verified
- Jun 2013
- First submitted
- 14 Sep 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boisson S, Stevenson M, Shapiro L, Kumar V, Singh LP, Ward D, Clasen T. Effect of household-based drinking water chlorination on diarrhoea among children under five in Orissa, India: a double-blind randomised placebo-controlled trial. PLoS Med. 2013 Aug;10(8):e1001497. doi: 10.1371/journal.pmed.1001497. Epub 2013 Aug 20.
PubMed 23976883
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Household-based Chlorination of Drinking Water to Prevent Diarrhoeal Disease: a Randomized, Placebo-controlled Trial in India Using Sodium Dichloroisocyanurate (NaDCC) Tablets
- ClinicalTrials.gov ID
- NCT01202383
- Acronym / sponsor ID
- EH224
- Conditions
- Diarrhoea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,163 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Population Services International, Partners for Affordable Technologies in Health, United States Agency for International Development (USAID), Chemical Council of America, Medentech, Indian Institute of Health Management Research
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Sep 2010 (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 proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. For more than a century, chlorine has be used to treat water in municipal systems in developed countries. Lack of infrastructure has prevented its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for more than 30 years in emergencies and has recently been approved for routine treatment of drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of the food-grade ingredients in the effective tablet, without the chlorine. Study participants will be supplied with tablets (intervention or placebo) and instructed to use the same to treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and weight-for-age Z scores in <5s. Chlorine residual and bacteriological quality of water stored in the home will be measured each month. The study will also assess the impact of the intervention on absenteeism from school and work and on health care expenditure for diarrhoea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NADCC tablets | Active comparator | Behavioral: Household-based water treatment with NADCC tablets |
| Placebo tablets | Placebo comparator | Behavioral: Household-based water treatment with placebo tablets |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Households with at least one child< 5
- Male and female head of household consent to participate
- Reside permanently in study area
Key exclusion criteria (0 listed)
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-based water treatment with NADCC tabletsStudy participants will be supplied with tablets and encouraged to use them for treating their water daily | Behavioural | NADCC tablets |
| Household-based water treatment with placebo tabletsStudy participants will be supplied with tablets and encouraged to use them for treating their water daily | Behavioural | Placebo tablets |
Primary outcome
diarrhoea morbidity
Time frame: monthly visits for 12 months
diarrhoea will be recorded among <5s and all ages
5 secondary outcomes
weight for age Z-score
Time frame: monthly visits for 12 months
bacteriological water quality in household storage container
Time frame: monthly visits for 12 months
residual chlorine in household storage container
Time frame: monthly visits for 12 months
absenteeism from school and work
Time frame: monthly visits over 12 months
health care expenditure for diarrhea
Time frame: One time visit
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 19 Jun 2013.
- Derived from this study: PubMed 23976883Boisson S, Stevenson M, Shapiro L, Kumar V, Singh LP, Ward D, Clasen T. Effect of household-based drinking water chlorination on diarrhoea among children under five in Orissa, India: a double-blind randomised placebo-controlled trial. PLoS Med. 2013 Aug;10(8):e1001497. doi: 10.1371/journal.pmed.1001497. Epub 2013 Aug 20.
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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.
Thomas Clasen, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Household-based water treatment with NADCC tablets in people with Diarrhoea, run by London School of Hygiene and Tropical Medicine at 1 site in India.
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 0 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 19 Jun 2013. 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 India. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
diarrhoea morbidity (time frame: monthly visits for 12 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 NCT01202383, 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 19 Jun 2013.