Total Urinary ArsenicNCT02372851
Assessing the Effectiveness of a Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal
A study testing Pureit As+ Filter in people with Total Urinary Arsenic and Total Arsenic in Water, run by London School of Hygiene and Tropical Medicine at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Total Urinary Arsenic, Total Arsenic in Water, Diarrhoeal Disease
- What is being tested?
- Pureit As+ Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
India1 site
Gobardanga Seba Farmer's Samity (GSFS)
Gobardanga, North 24 Parganas, West Bengal
About this study
Official title: Assessing the Effectiveness of a Point-of-use Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal
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.
Read the detailed description
The Unilever Pureit As+ filter will be assessed for chemical and microbiological performance and health impact using a parallel, household-randomised controlled trial (RCT) design over a four-month follow-up period.
This study will follow an open (non-blinded) design because filtration technologies are particularly challenging to blinding (Boisson et al., 2010). Equal randomisation will be applied (i.e. 1:1). Randomisation will be undertaken through a lottery organised in each participating village.
The study will be undertaken in two phases; an initial phase will involve a baseline survey in the identified affected communities. Those households identified as eligible during the baseline survey will then be randomised into the intervention or control group and the intervention will then be distributed. After a 2-4 week adaptation period, control and intervention arms will be followed at monthly visits for a period of four months.
The baseline study will collect information on demographics, sanitation facilities, hygiene practices, drinking water sources and treatment practices, diet of household members, knowledge of arsenic contamination and arsenicosis, and other factors that could potentially impact the outcomes of interest. Additionally, data on behavioural factors that have been observed to be associated with Household Water Treatment (HWT) use will be collected to predict intervention use in the intervention arm. During the baseline survey, water samples of source water and stored drinking water will be collected and tested for total thermotolerant coliforms (TTC) and total arsenic concentration. The female head of the household will be invited to provide a sample of urine for total urinary arsenic testing. The female head of the household will be followed because it is expected that she will be the household member that i. is mainly responsible for drinking water management, and ii. is at home most of the day and thus making it logistically feasible to obtain spot urine samples throughout the study.
At monthly intervals, participating households will be visited to assess filter use using self report as well as objective indicators. Additionally, in each round of follow-up, drinking water samples will be taken in all participating households for both microbiological and arsenic testing. Additionally, the female head of household will be invited to provide spot urine samples for total urinary arsenic at each round of follow up.
For arsenic testing samples of stored drinking water will be collected and analysed for total arsenic. Additionally, in intervention households, samples of source water will also be collected to assess the percentage removal of Arsenic by the Pureit AS+ filter. Water samples will be collected in polyethylene bottles pre-washed with nitric acid water and nitric acid (0.1% v/v) will be added after collection at the laboratory as a preservative (Roychowdhury, 2008). Samples will be stored in ice box until arrival to the lab and stored at 4°C until shipment to the laboratory for analysis. Total water arsenic will be measured by Flow Injection Hydride Generation Atomic Absorption Spectrometry (FI-HG-AAS) and or Inductively coupled plasma mass spectrometry (ICP-MS).
For microbiological testing, in each round of follow-up, in intervention households water samples will be collected of i. stored drinking water (whether this is from the intervention filter or another container), ii. in a 25% random sample, samples will also be taken of influent water (source water) and effluent water out of the filter (if they keep their drinking water elsewhere). For control households, water samples will be collected of i. stored drinking water and, ii. in a 25% random sample, from the water source. Untreated drinking water will be collected to determine technology performance by comparing effluent and influent water quality. For the stored drinking water, the householder will be asked if there is any drinking water in the house at that moment and a sample will be collected from the vessel that the householder identifies as being the main container used at that moment to fill a cup or glass for drinking. All samples for microbial analysis will be collected in sterile Whirl-Pak™ bags containing a tablet of sodium thiosulfate to neutralize any disinfectant. Samples will be placed on ice and processed within 4-6 hours of collection to assess TTC levels. Microbiological assessment will be performed using a DelAgua field incubator (University of Surrey) in accordance with Standard Methods (Eaton et al., 2005).
Acceptability and major limitations with the filtration technology will be assessed during the final follow-up visit. The acceptability of the technology will be evaluated by conducting household surveys, in-depth interviews (IDI) and focus group discussions (FGDs). A subsample of male and female heads of households will be asked to participate in FGDs at the end of the study to provide feedback on the technology including perceived benefits and limitations.
- Being tested
- Pureit As+ Filter
- Keywords
- Arsenic, Household water treatment, Point of use water treatment, Water Quality, Total Urinary Arsenic, West Bengal, Thermotolerant coliforms, Compliance, Diarrhoea
- Medical subject headings
- Patient Compliance, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (8)
Total arsenic removal in drinking water
Median and arithmetic mean of total arsenic concentration in intervention vs. control households stored drinking water
Measured: 4 months
Total arsenic reduction in filtered water
To assess total arsenic removal performance in drinking water of the Unilever Pureit As+ technology in the field (Mean % removal).
Measured: 4 months
Mean TTC reduction in drinking water
Williams mean of CFU/100 mL in intervention vs. control household stored drinking water
Measured: 4 months
Self-reported use of the intervention
To examine consistent use of Unilever Pureit As+ technology, for children <5 years and all household members
Measured: 4 months
Consistent use
To examine consistent use of Unilever Pureit As+ technology using objective indicators of use
Measured: 4 months
Prevalence of diarrhoea among <5s
To examine the impact of the Unilever Pureit As+ technology on reported diarrhoea among children under 5 years
Measured: 4 months
Prevalence of diarrhoea among all family members
- To examine the impact of the Unilever Pureit As+ technology on reported diarrhoea among all family members.
Measured: 4 months
Bacterial removal
Mean % removal (log reduction) of TTC for intervention households
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Urinary ArsenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kalyani, KIIT University, Hindustan Unilever Ltd.
- Responsible party
- Sponsor
- Investigators
- Thomas Clasen, JD MSc PhD, Principal investigator, LSHTM & Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372851
- Sponsor's protocol ID
- LondonSHTM
- Status last verified
- Sep 2015
- First submitted
- 20 Feb 2015
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a Point-of-use Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal
- ClinicalTrials.gov ID
- NCT02372851
- Acronym / sponsor ID
- LondonSHTM
- Keywords
- Arsenic, Household water treatment, Point of use water treatment, Water Quality, Total Urinary Arsenic, West Bengal, Thermotolerant coliforms, Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Kalyani, KIIT University, Hindustan Unilever Ltd.
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Unilever Pureit As+ filter will be assessed for chemical and microbiological performance and health impact using a parallel, household-randomised controlled trial (RCT) design over a four-month follow-up period.
This study will follow an open (non-blinded) design because filtration technologies are particularly challenging to blinding (Boisson et al., 2010). Equal randomisation will be applied (i.e. 1:1). Randomisation will be undertaken through a lottery organised in each participating village.
The study will be undertaken in two phases; an initial phase will involve a baseline survey in the identified affected communities. Those households identified as eligible during the baseline survey will then be randomised into the intervention or control group and the intervention will then be distributed. After a 2-4 week adaptation period, control and intervention arms will be followed at monthly visits for a period of four months.
The baseline study will collect information on demographics, sanitation facilities, hygiene practices, drinking water sources and treatment practices, diet of household members, knowledge of arsenic contamination and arsenicosis, and other factors that could potentially impact the outcomes of interest. Additionally, data on behavioural factors that have been observed to be associated with Household Water Treatment (HWT) use will be collected to predict intervention use in the intervention arm. During the baseline survey, water samples of source water and stored drinking water will be collected and tested for total thermotolerant coliforms (TTC) and total arsenic concentration. The female head of the household will be invited to provide a sample of urine for total urinary arsenic testing. The female head of the household will be followed because it is expected that she will be the household member that i. is mainly responsible for drinking water management, and ii. is at home most of the day and thus making it logistically feasible to obtain spot urine samples throughout the study.
At monthly intervals, participating households will be visited to assess filter use using self report as well as objective indicators. Additionally, in each round of follow-up, drinking water samples will be taken in all participating households for both microbiological and arsenic testing. Additionally, the female head of household will be invited to provide spot urine samples for total urinary arsenic at each round of follow up.
For arsenic testing samples of stored drinking water will be collected and analysed for total arsenic. Additionally, in intervention households, samples of source water will also be collected to assess the percentage removal of Arsenic by the Pureit AS+ filter. Water samples will be collected in polyethylene bottles pre-washed with nitric acid water and nitric acid (0.1% v/v) will be added after collection at the laboratory as a preservative (Roychowdhury, 2008). Samples will be stored in ice box until arrival to the lab and stored at 4°C until shipment to the laboratory for analysis. Total water arsenic will be measured by Flow Injection Hydride Generation Atomic Absorption Spectrometry (FI-HG-AAS) and or Inductively coupled plasma mass spectrometry (ICP-MS).
For microbiological testing, in each round of follow-up, in intervention households water samples will be collected of i. stored drinking water (whether this is from the intervention filter or another container), ii. in a 25% random sample, samples will also be taken of influent water (source water) and effluent water out of the filter (if they keep their drinking water elsewhere). For control households, water samples will be collected of i. stored drinking water and, ii. in a 25% random sample, from the water source. Untreated drinking water will be collected to determine technology performance by comparing effluent and influent water quality. For the stored drinking water, the householder will be asked if there is any drinking water in the house at that moment and a sample will be collected from the vessel that the householder identifies as being the main container used at that moment to fill a cup or glass for drinking. All samples for microbial analysis will be collected in sterile Whirl-Pak™ bags containing a tablet of sodium thiosulfate to neutralize any disinfectant. Samples will be placed on ice and processed within 4-6 hours of collection to assess TTC levels. Microbiological assessment will be performed using a DelAgua field incubator (University of Surrey) in accordance with Standard Methods (Eaton et al., 2005).
Acceptability and major limitations with the filtration technology will be assessed during the final follow-up visit. The acceptability of the technology will be evaluated by conducting household surveys, in-depth interviews (IDI) and focus group discussions (FGDs). A subsample of male and female heads of households will be asked to participate in FGDs at the end of the study to provide feedback on the technology including perceived benefits and limitations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pureit As+ Filter | Active comparator | Device: Pureit As+ FilterEach 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pureit As+ FilterThe 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). | Device | Pureit As+ Filter |
Primary outcome
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
8 secondary outcomes
Total arsenic removal in drinking water
Time frame: 4 months
Total arsenic reduction in filtered water
Time frame: 4 months
Mean TTC reduction in drinking water
Time frame: 4 months
Self-reported use of the intervention
Time frame: 4 months
Consistent use
Time frame: 4 months
Prevalence of diarrhoea among <5s
Time frame: 4 months
Prevalence of diarrhoea among all family members
Time frame: 4 months
Bacterial removal
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Clasen, JD MSc PhD principal investigator
LSHTM & Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pureit As+ Filter in people with Total Urinary Arsenic and Total Arsenic in Water, run by London School of Hygiene and Tropical Medicine at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total urinary arsenic (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.