DiarrheaNCT00252928
Health Impact Study of Aquatabs in Tamale, Ghana
A study testing Sodium dichloroisocyanurate (NaDCC) tablets in people with Diarrhea, run by Centers for Disease Control and Prevention at 3 sites in 2 countries.
Trial summary
The purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces diarrheal diseases in a peri-urban population of Tamale, Ghana. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Sodium dichloroisocyanurate (NaDCC) tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2006to Nov 2006
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Households with at least one child under 5 years old
Who cannot join
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States1 site
Emory University Center for Global Safe Water
Atlanta, Georgia, 30322
About this study
Official title: Health Impact Study of a Water Treatment Tablet, Aquatabs, in Tamale, Ghana
The purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces diarrheal diseases in a peri-urban population of Tamale, Ghana.
- Conditions
- Diarrhea
- Being tested
- Sodium dichloroisocyanurate (NaDCC) tablets, Placebo
- Keywords
- sodium dichloroisocyanurate, water purification, disinfection, Ghana
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium dichloroisocyanurate (NaDCC) tabletsOther
Also called Aquatabs
Intervention arm receives NaDCC tablets to use for to disinfect their household water for use for 20L of water. Ideally, disinfection occurs every day.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo group does not receive Aquatabs. Receives: Other: Placebo |
| B | Experimental | Intervention arms receives Aquatabs. Receives: Other: Sodium dichloroisocyanurate (NaDCC) tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the impact of Aquatabs on diarrhea among persons in households in Tamale, Ghana.
Measured: 12 weeks
Secondary outcomes (2)
Assess the microbiological quality of household water among persons living in Tamale, Ghana.
Measured: 12 weeks
Determine the acceptability of Aquatabs.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJul 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Medentech, Emory University Center for Global Safe Water, NewEnergy, University for Development Studies, Tamale, Ghana
- Investigators
- Seema Jain, MD, Principal investigator, Centers for Disease Control and PreventionRobert Quick, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252928
- Sponsor's protocol ID
- CDC-NCID-4730
- Status last verified
- Oct 2007
- First submitted
- 10 Nov 2005
- Last updated
- 30 Oct 2007
- Results posted
- No
Publications
Mintz ED, Reiff FM, Tauxe RV. Safe water treatment and storage in the home. A practical new strategy to prevent waterborne disease. JAMA. 1995 Mar 22-29;273(12):948-53.
PubMed 7884954Reiff FM, Roses M, Venczel L, Quick R, Witt VM. Low-cost safe water for the world: a practical interim solution. J Public Health Policy. 1996;17(4):389-408.
PubMed 9009536Quick RE, Venczel LV, Mintz ED, Soleto L, Aparicio J, Gironaz M, Hutwagner L, Greene K, Bopp C, Maloney K, Chavez D, Sobsey M, Tauxe RV. Diarrhoea prevention in Bolivia through point-of-use water treatment and safe storage: a promising new strategy. Epidemiol Infect. 1999 Feb;122(1):83-90. doi: 10.1017/s0950268898001782.
PubMed 10098789Quick RE, Venczel LV, Gonzalez O, Mintz ED, Highsmith AK, Espada A, Damiani E, Bean NH, De Hannover EH, Tauxe RV. Narrow-mouthed water storage vessels and in situ chlorination in a Bolivian community: a simple method to improve drinking water quality. Am J Trop Med Hyg. 1996 May;54(5):511-6. doi: 10.4269/ajtmh.1996.54.511.
PubMed 8644907Sobel J, Mahon B, Mendoza CE, Passaro D, Cano F, Baier K, Racioppi F, Hutwagner L, Mintz E. Reduction of fecal contamination of street-vended beverages in Guatemala by a simple system for water purification and storage, handwashing, and beverage storage. Am J Trop Med Hyg. 1998 Sep;59(3):380-7. doi: 10.4269/ajtmh.1998.59.380.
PubMed 9749629
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Impact Study of a Water Treatment Tablet, Aquatabs, in Tamale, Ghana
- ClinicalTrials.gov ID
- NCT00252928
- Acronym / sponsor ID
- CDC-NCID-4730
- Conditions
- Diarrhea
- Keywords
- sodium dichloroisocyanurate, water purification, disinfection, Ghana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Medentech, Emory University Center for Global Safe Water, NewEnergy, University for Development Studies, Tamale, Ghana
- Study start
- Jul 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Nov 2005 (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 purpose of this study to determine whether Aquatabs, a water treatment tablet, reduces diarrheal diseases in a peri-urban population of Tamale, Ghana.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Other: PlaceboPlacebo group does not receive Aquatabs. |
| B | Experimental | Other: Sodium dichloroisocyanurate (NaDCC) tabletsIntervention arms receives Aquatabs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Households with at least one child under 5 years old
Key exclusion criteria (1 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 |
|---|---|---|
| Sodium dichloroisocyanurate (NaDCC) tabletsAlso: AquatabsIntervention arm receives NaDCC tablets to use for to disinfect their household water for use for 20L of water. Ideally, disinfection occurs every day. | Other | B |
| PlaceboPlacebo | Other | A |
Primary outcome
Measure the impact of Aquatabs on diarrhea among persons in households in Tamale, Ghana.
Time frame: 12 weeks
2 secondary outcomes
Assess the microbiological quality of household water among persons living in Tamale, Ghana.
Time frame: 12 weeks
Determine the acceptability of Aquatabs.
Time frame: 12 weeks
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 30 Oct 2007.
- Background: PubMed 7884954Mintz ED, Reiff FM, Tauxe RV. Safe water treatment and storage in the home. A practical new strategy to prevent waterborne disease. JAMA. 1995 Mar 22-29;273(12):948-53.
- Background: PubMed 9009536Reiff FM, Roses M, Venczel L, Quick R, Witt VM. Low-cost safe water for the world: a practical interim solution. J Public Health Policy. 1996;17(4):389-408.
- Background: PubMed 10098789Quick RE, Venczel LV, Mintz ED, Soleto L, Aparicio J, Gironaz M, Hutwagner L, Greene K, Bopp C, Maloney K, Chavez D, Sobsey M, Tauxe RV. Diarrhoea prevention in Bolivia through point-of-use water treatment and safe storage: a promising new strategy. Epidemiol Infect. 1999 Feb;122(1):83-90. doi: 10.1017/s0950268898001782.
- Background: PubMed 8644907Quick RE, Venczel LV, Gonzalez O, Mintz ED, Highsmith AK, Espada A, Damiani E, Bean NH, De Hannover EH, Tauxe RV. Narrow-mouthed water storage vessels and in situ chlorination in a Bolivian community: a simple method to improve drinking water quality. Am J Trop Med Hyg. 1996 May;54(5):511-6. doi: 10.4269/ajtmh.1996.54.511.
- Background: PubMed 9749629Sobel J, Mahon B, Mendoza CE, Passaro D, Cano F, Baier K, Racioppi F, Hutwagner L, Mintz E. Reduction of fecal contamination of street-vended beverages in Guatemala by a simple system for water purification and storage, handwashing, and beverage storage. Am J Trop Med Hyg. 1998 Sep;59(3):380-7. doi: 10.4269/ajtmh.1998.59.380.
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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.
Seema Jain, MD principal investigator
Centers for Disease Control and Prevention
Robert Quick, MD principal investigator
Centers for Disease Control and Prevention
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium dichloroisocyanurate (NaDCC) tablets in people with Diarrhea, run by Centers for Disease Control and Prevention at 3 sites in 2 countries.
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 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ghana, United States. 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.
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?
Measure the impact of Aquatabs on diarrhea among persons in households in Tamale, Ghana. (time frame: 12 weeks). 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 NCT00252928, which also lists 5 linked publications.
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 30 Oct 2007.