Automatic Chlorination and Child Health in Urban Bangladesh

NCT ID: NCT02606981

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1549 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-20

Brief Summary

Municipal water networks within industrialized countries typically rely on centralized treatment to manage piped water quality. Optimal water quality at the tap, however, requires well-maintained piped distribution networks, and performs best when piped systems are fully pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately maintained and typically supply intermittent service; as such, they are vulnerable to recontamination during negative pressure events. Among populations accessing these types of improved water sources in urban settings (e.g. shared taps), it is unknown if consistent treatment to provide chlorinated water at the point of collection would have a significant health benefit. Furthermore, almost all previous studies of water treatment interventions in low-income countries have been unblinded with self-reported diarrhea as the main outcome, casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to social desirability bias. Stanford University in collaboration with icddr,b will conduct a randomized evaluation to assess the impact on access to automatically chlorinated water on water quality and child health.

Detailed Description

Investigators will conduct a blinded cluster randomized controlled trial to evaluate the health and economic impacts of having access to automatically chlorinated water. The unit of randomization will be shared water points that typically serve 20-200 households. Shared water points connected to holding tanks compatible with the water treatment technology, and serving more than 4 households with at least one child under five, will be identified. Households accessing eligible water points as their primary drinking water source will be enrolled before installation of chlorine devices, and a baseline survey will be conducted of water quality, diarrhea prevalence, and health care expenditures. Following this baseline, households will be randomly assigned to control or treatment groups. The chlorination devices will be installed at the treatment group water points, while a doser containing vitamin C (and no chlorine), will be installed in the control group. The free chlorine dosing target will be below <1ppm to preserve blinding. All households will be surveyed every 2-3 months for a total follow up period of 14-16 months (5-7 survey rounds, budget permitting).

Objectives:

1. To evaluate the impact of an automated chlorination system on microbial stored drinking water quality, residual chlorine, user satisfaction, user perceptions of water taste and smell, under-five child diarrhea (longitudinal prevalence) compared to a control group.

2. Compare the marginal additional cost (per person served) of installing and maintaining an automated chlorination system integrated with the current water supply infrastructure in low-income areas of Dhaka.

3. Assess the impact of an automated chlorination system on hospital visits and health care expenditures.

4. To measure secondary outcomes of the impact of an automated chlorination system including under-five child weight-for-age (WAZ), under-five height-for-age (HAZ), as well as levels of C-reactive protein and immunoglobin G in serum samples collected from children under five (these are objective indicators of infection, such as repeat diarrheal episodes).

Analysis:

The primary analyses will be intent-to-treat (investigators will analyze differences in outcomes between the treatment and control groups, with groups defined by their random allocation). Investigators will also conduct a secondary analysis comparing outcomes between intervention and control, where the intervention group is defined as those households that had free chlorine residual detected in their stored drinking water (treated on the treated analysis).

Conditions

Diarrhea; Communicable Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Chlorination

Device: Water chlorination by the Flogenic Primary drinking water source will be outfitted with automatic dosing device supplied with chlorine tablets. The device is called the Flogenic.

Group Type: EXPERIMENTAL

Water chlorination by the Flogenic

Intervention Type: DEVICE

The chlorine doser delivers a constant amount of chlorine into water as it flows into a holding tank. The water is then piped to public and private taps.

Control

Active control: Vitamin C dosing into water. Primary drinking water source will be outfitted with automatic dosing device supplied with vitamin C tablets. The device is not commercially available.

Group Type: PLACEBO_COMPARATOR

Active control, vitamin C dosing into water

Intervention Type: DEVICE

The control group will receive a vitamin C dosing device that looks identical to the intervention chlorine doser installed in the holding tank that feeds their shared water access point.

Interventions

Water chlorination by the Flogenic

The chlorine doser delivers a constant amount of chlorine into water as it flows into a holding tank. The water is then piped to public and private taps.

Intervention Type: DEVICE

Active control, vitamin C dosing into water

The control group will receive a vitamin C dosing device that looks identical to the intervention chlorine doser installed in the holding tank that feeds their shared water access point.

Intervention Type: DEVICE

Other Intervention Names

Flogenic by Medentech; Vitamin C dosing device (not commercially available)

Eligibility Criteria

Inclusion Criteria

• Households with at least one child under 60 months old
• Households using enrolled shared water point as primary drinking water source

Exclusion Criteria

• Households with a private drinking water source

Note: New births and children under 60 months that migrate into compounds accessing the enrolled water points for drinking water will be enrolled into the study.

• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stephen P Luby

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Luby, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Amy Pickering, PhD

Role: STUDY_DIRECTOR

Stanford University

Locations

Tongi and Dhaka Uddan

Tongi/Dhaka, Gazipur, Bangladesh

Countries

Bangladesh

References

Pickering AJ, Crider Y, Sultana S, Swarthout J, Goddard FG, Anjerul Islam S, Sen S, Ayyagari R, Luby SP. Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial. Lancet Glob Health. 2019 Sep;7(9):e1247-e1256. doi: 10.1016/S2214-109X(19)30315-8.

Reference Type: DERIVED

PMID: 31402005 (View on PubMed)

Other Identifiers

30456

Identifier Type: -

Identifier Source: org_study_id