| CTRI Number |
CTRI/2014/01/004322 [Registered on: 17/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
The practical applicability of membrane filtration at the source for supplying safe drinking water to rural populations in India |
|
Scientific Title of Study
|
Effectiveness and Feasibility of Membrane Filtration for Safe Drinking Water in Rural India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mark Rohit Francis |
| Designation |
Wellcome Masters Fellow |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Community Health,
Christian Medical College,
Bagayam,
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
|
| Fax |
|
| Email |
elysium28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mark Rohit Francis |
| Designation |
Wellcome Masters Fellow |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Community Health,
Christian Medical College,
Bagayam,
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
|
| Fax |
|
| Email |
elysium28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mark Rohit Francis |
| Designation |
Wellcome Masters Fellow |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Community Health,
Christian Medical College,
Bagayam,
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
|
| Fax |
|
| Email |
elysium28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Wellcome Trust Masters training Fellowship in Public Health and Tropical Medicine |
|
|
Primary Sponsor
|
| Name |
Wellcome Trust |
| Address |
Wellcome Trust, Gibbs Building, 215 Euston Road, London NW1 2BE, UK
|
| Type of Sponsor |
Other [International funder] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mark Rohit Francis |
Vellore |
Department of Community Health,
Christian Medical College,
Bagayam, Vellore - 632002
Vellore
TAMIL NADU |
8870960953
elysium28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Families with children under 2 years of age who will be followed up for a duration of one year for any form of enteric infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Skyhydrant membrane filtered water |
Membrane filter fitted at source used to purify water obtained from Skyjuice foundation, Australia. It removes bacteria and viruses from water |
| Intervention |
Skyhydrant membrane filtered water and Narrow necked container with a tap for water storage |
Skyhydrant membrane filtration device sourced from Skyjuice foundation, Australia. Narrow necked container for water storage sourced locally. The Narrow necked container is intended to prevent the recontamination of water purified by the Skyhydrant in the household. |
| Comparator Agent |
Water purification as per Tamil Nadu Water and Drainage Board (TWAD) Guidelines |
Source water purification as prescribed by the TWAD board for disinfecting water in rural Vellore which is chlorination in the water storage tanks using prescribed doses of bleaching powder every 15 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Children under 2 years of age (Follow up for enteric infections for babies will only begin after weaning) |
|
| ExclusionCriteria |
| Details |
Children over 2 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diarrhoeal episodes in children during one year of follow up |
Diarrhoeal episodes in children during one year of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of water samples immediately post-treatment with no detectable coliforms in 100 ml of tested water |
Water sampling is once monthly |
| Percentage of household stored water samples with no detectable coliforms in 100 ml of tested water |
Water sampling of household samples will be accomplished in 10% of study households taken once in two months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Recruitment of study participants in the 3 sites of study began on October 1, 2013. We are yet to meet the total sample size of 80 children per site. Recruitment will be ongoing until we reach 80 children per site, the study team is tracking ANC’s for the purpose, and we hope to have completed recruitment by the end of the year or early next year.
|