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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02441699
Other study ID # 9071
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2015
Est. completion date December 2019

Study information

Verified date August 2019
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.


Description:

We will undertake a matched-cohort study among 84 villages in Ganjam district, Orissa, India to assess the health impact of a program that provides improved water supplies and sanitation to rural villages.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2940
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Improved water supply and sanitation
Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.

Locations

Country Name City State
United Kingdom London School of Hygiene & Tropical Medicine London

Sponsors (6)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Bill and Melinda Gates Foundation, Emory University, Gram Vikas, Bhubanesar, Orissa, KIIT University, Bhubaneswar, Orissa, Loyola Hospital, Bhubaneswar, Orissa

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reported diarrhoea in children <5 years 7-day recall, assessed 4 times during 3-month follow-up rounds
Secondary Reported lower respiratory infection in children <5 7-day recall, assessed 4 times during 3-month follow-up rounds
Secondary Diarrhoea among all ages 7-day recall, assessed 4 times during 3-month follow-up roundsits
Secondary Lower respiratory infection among all ages 7-day recall, assessed 4 times during 3-month follow-up roundsts
Secondary Soil-transmitted helminth infection Stool samples taken and assayed for ascaris, trichuris, hookworm Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
Secondary Height-for-age among children < 2 years Children height measured and HAZ scores computed Assessed approximately every 90 days for a total of four measurement over study period
Secondary Weight-for-age among children <5 Children weighed and WAZ scores computed Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
Secondary Biomarkers of environmental enteropathy and enteric infection Assessed once during round 3 (approximately 180 to 240 days following commencement of study
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