Health Impact of Treating and Safely Storing Shallow Tubewell Drinking Water

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01350063
First received: May 4, 2011
Last updated: January 1, 2013
Last verified: May 2011
  Purpose

When shallow tubewells replaced highly contaminated surface water as the primary source of drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no reduction in diarrheal disease with this improvement in water source. This lack of improvement in transitioning to tubewells is consistent with the lack of significant health gains observed in intervention studies focusing on water quality improvements at the source. In contrast, high quality intervention studies that improve water quality at the point of use through treatment of water in households show a 39% reduction in diarrhea.

The primary objective of this study is within a typical setting in rural Bangladesh where households use shallow tubewell water for drinking. The investigators will randomly assign 1800 households who have a child between the ages of six months and two years to one of three groups. Group 1 will receive a safe water storage vessel with a lid and a narrow mouth/tap and Aquatabs, an effervescent water purification tablet that utilizes sodium dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention and continue their standard habits and practices. Every month a field research assistant will visit each participating household and collect information on the prevalence of diarrhea among children between the ages of six months and two years, as well as children between the ages of two and five years if present in the household. Diarrhea prevalence in the 48 hours and 7 days preceding the visit will be recorded. The investigators will compare the longitudinal prevalence of diarrhea between the following groups: (1) households that receive chlorine and storage container versus households that only receive storage container to assess the effect of chlorination, (2) households that only receive storage container versus households that receive no intervention to assess the effect of safe storage, and (3) households that receive chlorine and storage container versus households that receive no intervention to assess the combined effect of chlorination and safe storage.

Hypothesis:

Drinking water from shallow tubewells that are intermittently contaminated with enteric pathogens contributes importantly to diarrhea among children in rural Bangladesh.


Condition Intervention
Diarrhoeal Disease
Drug: Sodium dichloroisocyanurate (NaDCC) tablet (Aquatab)
Device: Water storage container (Jerry can)
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Health Impact of Treating and Safely Storing Shallow Tubewell Drinking Water

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Diarrhoeal incidence among children between 6 months to 5 years of age. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6 months' intervention. Follow-up will be done once in a month. Information on diarrhoeal episodes will be collected for 7 days prior to the follow-up day.


Enrollment: 1800
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aquatabs and Safe Storage Vessel
Households in this group will receive Aquatabs for water purification, a safe water storage container to prevent contamination during storage in the home, and training and encouragement to treat and safely store their water using the provided products.
Drug: Sodium dichloroisocyanurate (NaDCC) tablet (Aquatab)
One tablet should be added to 10L container, resulting in a free chlorine dose of 2 mg/L.
Other Name: Aquatab
Experimental: Safe Storage Vessel
Households in this group will receive a safe water storage container, and training and encouragement to safely store their water using the provided products. If our study shows that treatment of tubewell water at the household level is effective in protecting children's health, they will receive a six-month supply of water treatment tablets at the end of the study.
Device: Water storage container (Jerry can)
Shallow tubewell water should be stored in 10L container.
Other Name: Jerry can
Standard practice
Households in this group will not receive any water treatment or storage intervention during the study. They will continue their usual water collection and storage practices. If our study shows that treatment and safe storage of tubewell water at the household level is effective in protecting children's health, they will receive the same safe water storage container as Groups 1 and 2 as well as a six-month supply of water treatment tablets at the end of the study.
Other: No intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Using a shallow tubewell that is free from iron complaints as the bari's primary source of drinking water and
  • Having a child between the ages of six months and two years living in the bari

Exclusion Criteria:

  • Iron complaints of the shallow tubewell
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350063

Locations
Bangladesh
Fulbaria sub-district
Mymensingh, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Stephen P Luby, MD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01350063     History of Changes
Other Study ID Numbers: PR-10038
Study First Received: May 4, 2011
Last Updated: January 1, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
water
tubewell
diarrhea
chlorination
safe storage

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Troclosene
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Disinfectants

ClinicalTrials.gov processed this record on July 28, 2014