Home » Trials » SLCTR/2013/033
Mebendazole mass treatment and health education on reduction of reinfection rate of pinworm infection (Enterobius vermicularis) among the children aged three to seven years in low income settlements in the Colombo Municipal Council (CMC) Area, Sri Lanka
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SLCTR Registration Number
SLCTR/2013/033
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Mebendazole mass treatment and health education on reduction of reinfection rate of pinworm infection (Enterobius vermicularis) among the children aged three to seven years in low income settlements in the Colombo Municipal Council (CMC) Area, Sri Lanka
Public Title of Trial
Pinworm infection and control among children living in Low Income Settlements in Colombo Municipal Council area
Disease or Health Condition(s) Studied
Pin worm infection
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1147-6704
Any other number(s) assigned to the trial and issuing authority
P53/04/2013 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
What is the effectiveness of mebendazole mass treatment and health education on reduction of reinfection rate of pinworm among the children aged three to seven years in low income settlements in the Colombo Municipal Council (CMC) Area?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Factorial
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
The study consists of two interventions with a 2x2 factorial design and 4 arms.
Consenting participants will be randomized to one of the following arms 1. Positive Household + Routine Health Education arm 2. Positive Household + Special Health Education arm 3. All Household + Routine Health Education arm 4. All Household + Special Health Education arm
Positive Household Arm (PHA): two doses of State Pharmaceuticals Manufacturing Corporation (SPMC) mebendazole 100mg two weeks apart will be given only for pinworm positive participants and their households
All Household Arm (AHA) : two doses of SPMC mebendazole 100mg two weeks apart will be given for all participants and their households irrespective of pinworm egg positivity.
If a child cannot swallow, the tablet will be crushed and administered with small amount of water to avoid choking hazard. This method is recommended by the World Health Organization.
Routine Health Education Arm (RHA) : Routine health education during the treatment with mebendazole in clinical settings will be given. This will include onetime brief verbal advice on hand washing before meals and after defecation and washing of clothes.
Special Health Education Arm (SHA) : special health education will be given based on Participatory Hygiene and Sanitation Transformation (PHAST) approach. A comprehensive health promotion intervention has been developed for this purpose. Health education will be given at the household level, including parents other family members and children depending on the age sufficient for understanding. Being a pragmatic trial, the family members whoever would be available during the visits to register, distribution of swabs, collection of swabs and treatment will be incorporated for the health education. A health education leaflet will also be distributed.
Inclusion criteria
For randomization 1. Children aged completion of 3 years to completion of 7 years 2. Living in a low income settlement (LIS) for at least 1 year
For mass treatment and health education 1. Household members of the participants.
Exclusion criteria
Primary outcome(s)
|
1.
Pinworm egg positivity (using cellophane anal swab, CAS) |
[
|
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
1210
Countries of recruitment
Sri Lanka
Anticipated start date
2013-12-02
Anticipated end date
2014-05-31
Date of first enrollment
2014-01-09
Date of study completion
Recruitment status
Recruiting
Funding source
University Grants Commission, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2013-04-10
Approval number
P53/04/2013
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof.A.Pathmeswaran,
Professor in Public Health
Department of Public Health,
Faculty of Medicine,
University of Kelaniya,
Ragama
0094112953411
0112958337
pathmes@gmail.com
http://www.kln.ac.lk/medicine/index.php/departments/public-health
Contact Person for Public Queries
Balachandran Kumarendran
Lecturer in Public Health
Department of Public Health, Faculty of Medicine, Ragama, Sri Lanka
0094112953411
0094777277552
0112958337
drbkumaran@gmail.com
http://www.kln.ac.lk/medicine/index.php/departments/public-health
Primary study sponsor/organization
Department of Public Health
Faculty of Medicine, Ragama, Sri Lanka
0094112953411
0112958337
http://www.kln.ac.lk/medicine/index.php/departments/public-health
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
