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Assessing the Effectiveness of a Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372851
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : September 12, 2016
Sponsor:
Collaborators:
University of Kalyani
KIIT University
Hindustan Unilever Ltd.
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
The purpose of this study is to determine whether the use of a point-of-use water filtration technology can reduce the Arsenic content in drinking water and reduce the Arsenic body burden.

Condition or disease Intervention/treatment Phase
Total Urinary Arsenic Total Arsenic in Water Diarrhoeal Disease Device: Pureit As+ Filter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing the Effectiveness of a Point-of-use Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal
Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Arsenic

Arm Intervention/treatment
Active Comparator: Pureit As+ Filter
Each household will receive one water filter and a replacement battery for free during distribution. The intervention will be distributed door-to-door by the implementation team. Households will be trained on use and maintenance of the device according to the manufacturer's instructions. Households will be advised to drink exclusively from the water filter and to carry water with them if attending school or work. Households will also be advised to clean and cook their rice with filtered water only.
Device: Pureit As+ Filter
The Pureit As+ water filter has been developed to effectively remove arsenic (both arsenite and arsenate) from over 300 µg/L to less than 10 µg/L in addition to removing microbial contamination (Institution of Public Health Engineers, 2011). It has an end-of-life indicator and consumables that do not re-contaminate the environment when disposed (Institution of Public Health Engineers, 2011). The technology requires no electricity, but only the replacement of the battery after 1000 L of water filtered (approximately 100 days based on a family of five drinking 2 L/day).

No Intervention: Control arm
The control arm will be advised to continue with their traditional drinking water and cooking practices. The control arm will receive the intervention at the end of the study period.



Primary Outcome Measures :
  1. Total urinary arsenic [ Time Frame: 4 months ]
    To assess the effectiveness of the Unilever Pureit As+ technology in decreasing the body burden of arsenic, measured in terms of total urinary arsenic


Secondary Outcome Measures :
  1. Total arsenic removal in drinking water [ Time Frame: 4 months ]
    Median and arithmetic mean of total arsenic concentration in intervention vs. control households stored drinking water

  2. Total arsenic reduction in filtered water [ Time Frame: 4 months ]
    To assess total arsenic removal performance in drinking water of the Unilever Pureit As+ technology in the field (Mean % removal).

  3. Mean TTC reduction in drinking water [ Time Frame: 4 months ]
    Williams mean of CFU/100 mL in intervention vs. control household stored drinking water

  4. Self-reported use of the intervention [ Time Frame: 4 months ]
    To examine consistent use of Unilever Pureit As+ technology, for children <5 years and all household members

  5. Consistent use [ Time Frame: 4 months ]
    To examine consistent use of Unilever Pureit As+ technology using objective indicators of use

  6. Prevalence of diarrhoea among <5s [ Time Frame: 4 months ]
    To examine the impact of the Unilever Pureit As+ technology on reported diarrhoea among children under 5 years

  7. Prevalence of diarrhoea among all family members [ Time Frame: 4 months ]
    5) To examine the impact of the Unilever Pureit As+ technology on reported diarrhoea among all family members.

  8. Bacterial removal [ Time Frame: 4 months ]
    Mean % removal (log reduction) of TTC for intervention households



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Households will be eligible to participate in the study if (i) the water identified as drinking during the baseline survey has an arsenic concentration that exceeds 50 µg/L, when measured using a rapid portable field testing kit, (ii) an alternative arsenic mitigation project is not underway for the household at the time of enrolment, (iii) the household is within the designated geographical area of the study, (iv) the household lives permanently in the area and anticipates living in the area for the next 6 months, (v) the household is willing to participate and (vi) the female head of the household is at least 18 years, is able to provide consent (has no cognitive impairments) and accepts to provide urine samples.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372851


Locations
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India
Gobardanga Seba Farmer's Samity (GSFS)
Gobardanga, North 24 Parganas, West Bengal, India
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Kalyani
KIIT University
Hindustan Unilever Ltd.
Investigators
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Principal Investigator: Thomas Clasen, JD MSc PhD LSHTM & Emory University
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02372851    
Other Study ID Numbers: LondonSHTM
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2015
Keywords provided by London School of Hygiene and Tropical Medicine:
Arsenic
Household water treatment
Point of use water treatment
Water Quality
Total Urinary Arsenic
West Bengal
Thermotolerant coliforms
Compliance
Diarrhoea