Automatic Chlorination and Child Health in Urban Bangladesh

NCT02606981 | Completed DMC

• 1 other identifier: 30456
• Study Type: interventional
• Target: 1,549
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Communicable Diseases

Keywords

Water treatment; Child growth; Enteric infection

Outcome Measures

Primary Outcomes (1)

• Diarrhea longitudinal prevalence

  1-week recall period, case definition is 3 or more loose/watery bowel movements in 24 hours

  Measured every 2-3 months for 16 months post baseline

Secondary Outcomes (7)

• Weight-for-age-z-score

  Measured every 2-3 months for 16 months post baseline

• Height-for-age-z-score

  Measured at baseline and 16 months after baseline

• Respiratory illness longitudinal prevalence

  Measured every 2-3 months for 16 months post baseline

• C-reactive protein

  Measured at baseline and conclusion of study (16 months post baseline) among children under five

• total immunoglobin G (IgG)

  Measured at baseline and conclusion of study (16 months post baseline) among children under five

Other Outcomes (3)

• Microbial water quality

  Measured monthly among a subset of households, for 16 months post baseline

• Chlorine residual in household stored drinking water

  Measured every 2-3 months for 16 months post baseline

• health related treatment and associated cost

  Measured every 2-3 months for 16 months post baseline

Study Arms (2)

Chlorination

EXPERIMENTAL

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.

Device: Water chlorination by the Flogenic

Control

PLACEBO COMPARATOR

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.

Device: Active control, vitamin C dosing into water

Interventions

Water chlorination by the Flogenic 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.

Also known as: Flogenic by Medentech

Chlorination

Active control, vitamin C dosing into water 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.

Also known as: Vitamin C dosing device (not commercially available)

Control

Eligibility Criteria

• Age: Up to 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

Tongi and Dhaka Uddan

Tongi/Dhaka, Gazipur, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 31402005 DERIVED

MeSH Terms

Conditions

Diarrhea; Communicable Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes; Pathologic Processes

Study Officials

• Stephen Luby, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Amy Pickering, PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 17, 2015
• Study Start: July 1, 2015
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

BA (1)