NCT01376440

Brief Summary

The Millenium development goals (MDGs) call for reducing by half the proportion of people without sustainable access to safe drinking water. This goal was adopted in large part because safe drinking water has been seen as critical to fighting diarrheal disease. Source protection is considered the main intervention area to achieve this goal. However, research worldwide that has shown that even drinking water which is safe at the source is subject to frequent and extensive fecal contamination during collection, storage and use in the home. This contamination is through the introduction of cups, dippers or hands, contamination by flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can pose infectious disease risks if they become contaminated due to unsanitary collection, storage conditions and practices within households. To reduce this problem, point-of-use water treatment has been advocated as a means to substantially decrease the global burden of diarrhea and to contribute to the MDGs. However, research indicates that there are many unanswered questions around Household water treatment (HWT) that require small or medium scale epidemiological studies and randomized controlled trials, especially with regard to effectiveness, acceptability and identifying suitable target populations. Some of the most urgent questions to be resolved are:(1) How much of the currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted? (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease is high. hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive children? hypothesis: Do household water treatment with chlorine acceptable in the community?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
845

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

June 16, 2011

Last Update Submit

January 23, 2012

Conditions

Keywords

three or more loss stools in 24 hours

Outcome Measures

Primary Outcomes (1)

  • To assess the prevalence of diarrhea among under five children

    weekly visit of the household for the presence of diarrhoea among underfive for four months in both the intervention and control groups

    four months

Secondary Outcomes (2)

  • To assess the weight gain among the intervention and control groups of under five children

    At the beginning and end of the study ( 4 months interval)

  • Residual chlorine test

    four months

Study Arms (2)

Household water treatment

EXPERIMENTAL

household water treatment with 1.25% sodium hypochlorite

Other: household water treatment

control

NO INTERVENTION

Usual practice (the use of "Jerrican" for water storage, which is considered as safe storage)

Interventions

household water treatment with 1.25% sodium hypochlorite

Also known as: 1.25% sodium hypochlorite
Household water treatment

Eligibility Criteria

Age1 Month - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All children under five years of age in the randomly selected clusters of Kersa district

You may not qualify if:

  • seriously sick children in the randomly selected clusters of Kersa district

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kersa district

Kersa, Eastern Hararage, 235, Ethiopia

Location

Related Publications (1)

  • Mengistie B, Berhane Y, Worku A. Household water chlorination reduces incidence of diarrhea among under-five children in rural Ethiopia: a cluster randomized controlled trial. PLoS One. 2013 Oct 23;8(10):e77887. doi: 10.1371/journal.pone.0077887. eCollection 2013.

MeSH Terms

Interventions

Sodium Hypochlorite

Intervention Hierarchy (Ancestors)

Hypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Study Officials

  • Bezatu M Alemu, M.Sc

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations