Home » Trials » SLCTR/2015/012
Effects of Vitamin E Supplementation on the clinical outcome of Dengue Fever and Dengue Haemorrhagic Fever in Children
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SLCTR Registration Number
SLCTR/2015/012
Date of Registration
The date of last modification
Jul 09, 2019
Scientific Title of Trial
Effects of Vitamin E Supplementation on the clinical outcome of Dengue Fever and Dengue Haemorrhagic Fever in Children
Public Title of Trial
Effects of vitamin E in the treatment of dengue infection in children
Disease or Health Condition(s) Studied
Dengue Infection
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-15-011 (University of Colombo)
What is the research question being addressed?
What is the effect of vitamin E in reducing the morbidity associated with dengue infection compared to standard care alone?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Phase 4
Intervention(s) planned
Participants will be recruited from Ward 1, Lady Ridgeway Hospital (LRH). Consenting participants meeting inclusion/exclusion criteria will be randomized into two arms.
The intervention arm will receive a single daily dose of vitamin E orally (200mg in children between 5-9 years and 400mg in children between 10-12 years), from day of admission to day 7 of illness. Standard care will be provided according to National Guidelines.
The control arm will receive standard care only.
Inclusion criteria
Admission to the study setting (Ward 1, LRH) within 84 hours of the onset of fever
Clinical diagnosis of dengue infection (clinical criteria of the National Guidelines for Management of Dengue, Ministry of Health, Sri Lanka)
Exclusion criteria
Any underlying chronic disease (e.g. cardiac disease, renal disease, hepatic disease and muscular disorders)
Children on any long term medication
Primary outcome(s)
|
1.
Quantitative outcomes 1.1. Platelet count 1.2. Lowest platelet count 1.3. Haematocrit 1.4. Highest haematocrit 1.5. Duration of fever 1.6. Serum albumin |
[ Quantitative outcomes 1. On admission, day 3 and discharge 2. From time of admission to time of discharge All other outcomes will be assessed on day 1, day 3, day 5 and day 7 of illness ] |
|
2.
Qualitative outcomes 1.1. Entry into critical phase 1.2. Use of dextran 1.3. Presence of effusions on ultra sound scan 1.4. Need for catheterization |
[] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
100 (50 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-06-19
Anticipated end date
2015-09-14
Date of first enrollment
2015-08-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2015-04-23
Approval number
EC-15-011
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. V. Pujitha Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08, Sri Lanka.
+94 11 2688748
+94 77 7766595
+94 11 2691581
pujithaw@yahoo.com
Contact Person for Public Queries
Prof. V. Pujitha Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08, Sri Lanka.
+94 11 2688748
+94 77 7766595
+94 11 2691581
pujithaw@yahoo.com
Primary study sponsor/organization
Department of Paediatrics, Faculty of Medicine, University of Colombo
25, Kynsey Road, Colombo 08, Sri Lanka
Tel: +94112695300 (ext 331)
Fax: +94112691581
Email: paed_colombo@yahoo.com
Web: http://www.med.cmb.ac.lk/index.php/2012-05-16-05-13-13/paediatrics
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
