Health Impact of Treating and Safely Storing Shallow Tubewell Drinking Water

NCT01350063 | Completed DMC

• 1 other identifier: PR-10038
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhoeal Disease

Keywords

water; tubewell; diarrhea; chlorination; safe storage

Outcome Measures

Primary Outcomes (1)

• Diarrhoeal incidence among children between 6 months to 5 years of age.

  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.

  6 months

Study Arms (3)

Aquatabs and Safe Storage Vessel

EXPERIMENTAL

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)

Safe Storage Vessel

EXPERIMENTAL

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)

Standard practice

OTHER

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

Interventions

Sodium dichloroisocyanurate (NaDCC) tablet (Aquatab) DRUG

One tablet should be added to 10L container, resulting in a free chlorine dose of 2 mg/L.

Also known as: Aquatab

Aquatabs and Safe Storage Vessel

Water storage container (Jerry can) DEVICE

Shallow tubewell water should be stored in 10L container.

Also known as: Jerry can

Safe Storage Vessel

No intervention OTHER

Standard practice

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Iron complaints of the shallow tubewell

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Fulbaria sub-district

Mymensingh, Bangladesh

Location

Related Publications (1)

• Ercumen A, Naser AM, Unicomb L, Arnold BF, Colford JM Jr, Luby SP. Effects of source- versus household contamination of tubewell water on child diarrhea in rural Bangladesh: a randomized controlled trial. PLoS One. 2015 Mar 27;10(3):e0121907. doi: 10.1371/journal.pone.0121907. eCollection 2015.

  PMID: 25816342 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

troclosene; Tablets

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Stephen P Luby, MD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 9, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2011-05

Locations

BA (1)