NCT02372851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

February 20, 2015

Last Update Submit

September 9, 2016

Conditions

Total Urinary ArsenicTotal Arsenic in WaterDiarrhoeal Disease

Keywords

ArsenicHousehold water treatmentPoint of use water treatmentWater QualityTotal Urinary ArsenicWest BengalThermotolerant coliformsComplianceDiarrhoea

Outcome Measures

Primary Outcomes (1)

  • Total urinary arsenic

    To assess the effectiveness of the Unilever Pureit As+ technology in decreasing the body burden of arsenic, measured in terms of total urinary arsenic

    4 months

Secondary Outcomes (8)

  • Total arsenic removal in drinking water

    4 months

  • Total arsenic reduction in filtered water

    4 months

  • Mean TTC reduction in drinking water

    4 months

  • Self-reported use of the intervention

    4 months

  • Consistent use

    4 months

  • +3 more secondary outcomes

Study Arms (2)

Pureit As+ Filter

ACTIVE COMPARATOR

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

Control arm

NO INTERVENTION

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.

Interventions

Pureit As+ FilterDEVICE

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).

Pureit As+ Filter

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Gobardanga Seba Farmer's Samity (GSFS)

Gobardanga, North 24 Parganas, West Bengal, India

Location

MeSH Terms

Conditions

Patient ComplianceDiarrhea

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Clasen, JD MSc PhD

    LSHTM & Emory University

    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

February 20, 2015

First Posted

February 26, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 12, 2016

Record last verified: 2015-09

Locations

IN(1)