Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01350063 |
| Other study ID # |
PR-10038 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 4, 2011 |
| Last updated |
January 1, 2013 |
| Start date |
February 2011 |
| Est. completion date |
May 2012 |
Study information
| Verified date |
May 2011 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Bangladesh: Ethical Review Committee |
| Study type |
Interventional
|
Clinical Trial Summary
When shallow tubewells replaced highly contaminated surface water as the primary source of
drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no
reduction in diarrheal disease with this improvement in water source. This lack of
improvement in transitioning to tubewells is consistent with the lack of significant health
gains observed in intervention studies focusing on water quality improvements at the source.
In contrast, high quality intervention studies that improve water quality at the point of
use through treatment of water in households show a 39% reduction in diarrhea.
The primary objective of this study is within a typical setting in rural Bangladesh where
households use shallow tubewell water for drinking. The investigators will randomly assign
1800 households who have a child between the ages of six months and two years to one of
three groups. Group 1 will receive a safe water storage vessel with a lid and a narrow
mouth/tap and Aquatabs, an effervescent water purification tablet that utilizes sodium
dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water
storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention
and continue their standard habits and practices. Every month a field research assistant
will visit each participating household and collect information on the prevalence of
diarrhea among children between the ages of six months and two years, as well as children
between the ages of two and five years if present in the household. Diarrhea prevalence in
the 48 hours and 7 days preceding the visit will be recorded. The investigators will compare
the longitudinal prevalence of diarrhea between the following groups: (1) households that
receive chlorine and storage container versus households that only receive storage container
to assess the effect of chlorination, (2) households that only receive storage container
versus households that receive no intervention to assess the effect of safe storage, and (3)
households that receive chlorine and storage container versus households that receive no
intervention to assess the combined effect of chlorination and safe storage.
Hypothesis:
Drinking water from shallow tubewells that are intermittently contaminated with enteric
pathogens contributes importantly to diarrhea among children in rural Bangladesh.
Description:
Setting: The investigators will conduct the study in the Fulbaria upazila of Mymensingh
district, where groundwater chemistry has been proven to be amenable to disinfection with
chlorine. Groundwater in many areas in Bangladesh is rich in iron and other ions that react
with chlorine and limit its capacity to provide adequate disinfection. Groundwater testing
in Fulbaria has shown that chlorination works effectively at this location, as discussed
below.
Develop Intervention: This is an efficacy study, i.e. it is trying to answer the question:
if tubewell water were effectively chlorinated and/or safely stored in homes, what would be
the impact on childhood diarrhea. To efficiently answer this question, the investigators
will strive to optimize the use of the intervention in those households randomized to
receive the intervention. Chlorinating water has been shown to be an effective way of
disinfecting water in the home (Arnold and Colford, 2007). The investigators will use
Aquatabs for chlorination, which are effervescent water purification tablets that utilize
sodium dichloroisocyanurate (NaDCC) as the chlorine donor. NaDCC was judged to be a safe and
appropriate treatment for water by the World Health Organization (Clasen and Edmondson,
2006) and has been tested and found acceptable to a community of urban residents in Dhaka,
Bangladesh (Clasen et al., 2007a). Aquatabs are also easier to store, handle and correctly
dose than liquid forms of chlorine (Clasen and Edmondson, 2006).
Groundwater Testing: To optimize the use of Aquatabs and determine the appropriate dose to
be assigned to study participants, the investigators collected water samples from 52 shallow
tubewells geographically spread out over all 13 unions in Fulbaria. Water was collected in
5L and 10L jerry cans with a narrow mouth and lid. One Aquatabs tablet was added to each
vessel, resulting in a free chlorine dose of 2 mg/L in the 10L container and 4 mg/L in the
5L container. Remaining chlorine residual in the vessels was measured half an hour and 24
hours after the addition of the tablet to assess whether it meets the target criteria of
having a minimum residual of 0.2 mg/L at 24 hours (to ensure adequate disinfection) and a
maximum residual of 2 mg/L at half an hour (to minimize taste and odor concerns). It should
be noted that the 2 mg/L taste/odor threshold the investigators are targeting is well under
the WHO health limit of 5 mg/L. Based on the testing results, the investigators determined
that using one Aquatabs with a 10L jerry can provides the optimal chlorine dose in Fulbaria.
Intervention Groups: The study will have the following three arms, which will allow us to
establish the respective roles of household water treatment and safe water storage in
preventing diarrheal illness in children in the rural Bangladesh setting.
Group 1 - Aquatabs and Safe Storage Vessel: Households in this group will receive Aquatabs
for water purification, a safe water storage container to prevent contamination during
storage in the home, and training and encouragement to treat and safely store their water
using the provided products.
Group 2 - Safe Storage Vessel: Households in this group will receive a safe water storage
container, and training and encouragement to safely store their water using the provided
products. If our study shows that treatment of tubewell water at the household level is
effective in protecting children's health, they will receive a six-month supply of water
treatment tablets at the end of the study.
Group 3 - Standard Practices: Households in this group will not receive any water treatment
or storage intervention during the study. They will continue their usual water collection
and storage practices. If our study shows that treatment and safe storage of tubewell water
at the household level is effective in protecting children's health, they will receive the
same safe water storage container as Groups 1 and 2 as well as a six-month supply of water
treatment tablets at the end of the study.
Selection of Households: Households to participate in the study will be recruited through a
systematic sample from a subset of villages in Fulbaria selected based on field factors such
as ease of transport and proximity to the field office. The inclusion criteria will include
(1) using a shallow tubewell that is free from iron complaints as the bari's primary source
of drinking water and (2) having a child between the ages of six months and two years living
in the bari. The primary caregiver in the household that has the child in the target range
will be recruited into the study. If there are multiple households in the bari that have a
child between the ages of six months and two years, one of the households will be randomly
selected and the primary caregiver in the selected household will be recruited. Recruited
households will be randomized into one of the three study arms by block randomization
through a randomly generated, pre-established sequence that will determine which
intervention will be allocated to the household.
Promotion of Interventions: The intervention will continue for five months. At the first
visit to the households, Groups 1 and 2 will be provided with a plastic water storage
container with a lid and a narrow mouth/tap, and Group 1 will also be given a one-month
supply of tablets. Households will be taught through demonstrations and a flipchart with
illustrations how to use the tablets as well as how to properly use and clean the safe
storage containers, and they will be encouraged to use them regularly. They will also be
given an instructions sheet with illustrations that will be left at a visible spot in the
household and serve as a reminder to clean the containers and if applicable add the water
treatment tablets. A field research assistant who is not part of the evaluation team will
visit the household once per month to encourage regular water treatment and safe storage,
replenish the supply of tablets and address any issues with the maintenance and cleaning of
the safe storage vessels. The rest of the protocol has been written assuming that households
will receive monthly promotion visits. However, if the pilot study shows that more frequent,
intensive promotion leads to significantly better uptake, in the full-scale study the
investigators will consider replacing the monthly promotion frequency with more frequent
promotion visits.
Data Collection: There will be one baseline visit and five follow-up visits to participating
households.
Baseline Visit: The investigators will conduct a baseline survey including demographics,
household description, socioeconomic status, pre-intervention water, sanitation and hygiene
habits and baseline levels of diarrhea in children between the ages of six months and two
years. If there are any children in a recruited household that are between the ages of two
and five, the investigators will collect diarrhea data on them as well to allow comparison
of our results to other findings in the literature that focus on children under the age of
five. During the baseline visit, the investigators will assess the microbial quality of the
tubewell and stored water for each study household using the hydrogen sulphide (H2S) test.
Tubewell and stored water samples from a subset of 150 households (50 from each study arm)
will be analyzed for total coliforms and E. coli using membrane filtration.
Follow-Up Visits: Every month a field research assistant will visit each participating
household to conduct a follow-up survey and collect information on the prevalence of
diarrhea among children between the ages of six months and five years in the 48 hours as
well as 7 days preceding the visit. The investigators are using a 48-hour recall because
this typically provides a more valid estimate than longer recall periods which lead to
under-reporting of health outcomes (Alam et al., 1989, Ramakrishnan et al., 1999, Feikin et
al., 2010). The investigators are also using a 7-day recall because recent findings indicate
that while this longer recall period leads to only minimal bias in terms of the accuracy of
recall it can result in significant gains of statistical power (Arnold et al., unpublished
data). The investigators will visit households once every month, because more frequent
visits provide little additional statistical power due to correlation of repeated measures
on the same individuals (Schmidt et al., 2007).
At each visit, the investigators will also collect information on user compliance with the
interventions by asking about type and timing of water treatment practices, counting the
number of remaining tablets and inspecting the water storage facilities, as well as asking
participants when and how they cleaned the storage container. The investigators will also
collect water samples from the tubewell and storage container in households to assess the
microbial quality of the water, explore the extent of contamination at the source versus in
the home and gauge the effectiveness of the interventions in preventing contamination. The
investigators will perform H2S testing in half of study households and total coliform/E.coli
testing with membrane filtration for a subset of 150 households (50 from each study arm).
Moreover, for each household in the Aquatabs group, the investigators will analyze stored
water samples for residual chlorine concentration to monitor compliance with the
intervention.
Laboratory Testing: Water samples will be placed on ice and transported to the Fulbaria
field office where the appropriate tests will be conducted by the field microbiologists. All
testing will be performed promptly upon transporting the samples to the field office. The
hydrogen sulfide (H2S) test is a simple low-cost test (Sobsey and Pfaender, 2003). Twenty ml
of water will be added in H2S bottle and incubated at room temperature for 24-48 hours. If
the colour of the water changes to black, it will indicate that the water is contaminated
with coliform which will indicate that the water is unfit for human consumption. For
membrane filtration, collected water samples will be quantitatively tested for total
coliforms and E. coli using the DelAgua kit with MI Broth (Whatman Inc, New Jersey, USA).
For residual chlorine testing, the investigators will use the n,n-diethyl-p-phenylenediamine
(DPD) colorimetric method which is part of the DelAgua kit.
