Home » Trials » SLCTR/2023/007
Effect of Vitamin E supplementation on clinical outcomes and related hematological, biochemical, and oxidative stress parameters in 5 – 14-year-old children infected with dengue virus
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SLCTR Registration Number
SLCTR/2023/007
Date of Registration
The date of last modification
Jul 07, 2023
Scientific Title of Trial
Effect of Vitamin E supplementation on clinical outcomes and related hematological, biochemical, and oxidative stress parameters in 5 – 14-year-old children infected with dengue virus
Public Title of Trial
Effect of Vitamin E supplementation on clinical outcomes and related hematological, biochemical, and oxidative stress parameters in 5 – 14-year-old children infected with dengue fever
Disease or Health Condition(s) Studied
Dengue fever
Scientific Acronym
None
Public Acronym
None
Brief title
Effect of Vitamin E in the outcome of dengue infection in children
Universal Trial Number
U1111-1289-0861
Any other number(s) assigned to the trial and issuing authority
EC-22-099: Ethics Review Committee - Faculty of Medicine, University of Colombo
What is the research question being addressed?
Does vitamin E supplementation have a positive effect on clinical, heamatological, and biochemical outcomes and reduce oxidative stress in 5-14 year old children with dengue infection?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Investigators, Data analysts, Healthcare providers, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: Professorial Unit at the Lady Ridgeway Hospital.
Randomization method: Patients belong to the two age groups (5-8 yrs & 9-14 yrs) will be randomized to receive Vitamin E or not to receive vitamin E. randomization will be done using computer generated numbers
For each age category, each group will comprise of 30 subjects and finally each investigation arm will have 60 subjects each (of the two age groups). Vitamin E for children between 5 and 8 years of age will receive 200 mg(Evion®, Merk) daily and children between 9 and 14 years of age will receive 400 mg (EZY®, Celogen) daily. Dosage form: vitamin E gel capsules of either 200mg or 400 mg strength.
Starting point of intervention: when admitted under 84 hours from onset of illness and confirmed to be dengue infection (NS1 Positive). All patients will be given calcium lactate supplementation (1 mmol/kg/day) as it is part of the standard routine treatment protocol of the unit (Guidelines on Management of Dengue Fever &Dengue Haemorrhagic Fever in Children and Adolescents. Ministry of Health, Government of Sri Lanka. Nov 2012) Intervention and standard treatment will be done till completion of 7 days from onset of illness/temperature.
Inclusion criteria
Minimum age 5 and Maximum age 14-years Male or female Admitted within 84 hours of onset of fever, with Dengue NS 1 antigen positive.
Exclusion criteria
Any child with an underlying chronic illness such as cardiac, renal or hepatic disease or on any long term medications A child who cannot swallow a gel capsule
Primary outcome(s)
|
1.
• Occurrence of plasma leaking will be determined clinically (determined by presence of pleural effusion) or ultrasonically (presence of free fluid in the peritoneal cavity or pleural cavity) at any point during the hospital stay. Examinations will be done three times a day and USS will be done twice daily |
[ Daily from 2nd to 7th day of illness (from beginning of fever- during hospital stay) and at 10-14 days of illness ] |
Secondary outcome(s)
|
1.
• AST, ALT, serum albumin, bilirubin, serum calcium and uric acid from Day 3 to Day 7 of illness • TEAC (Trolox Equivalent Antioxidant Capacity), ABTS (2,2-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) from Day 3 to Day 7 of illness • Transferring to the ICU needed or not |
[ Daily from 2nd to 7th day of illness (from beginning of fever- during hospital stay) and at 10-14 days of illness ] |
Target number/sample size
120 (5-8 year age group 30- Vit E, 30 – Non Vit E: 9-14 year age group 30- Vit E, 30 – Non Vit E)
Countries of recruitment
Sri Lanka
Anticipated start date
2023-04-04
Anticipated end date
2023-10-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
NA
Status
Approved
Date of Approval
2023-02-16
Approval number
EC-22-099
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | Kynsey Road, Colombo 00800 |
| Telephone: | +94-11-2695300 ext 240 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Vithanage Pujitha Wickramasinghe
Senior Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 00800, Sri Lanka
+94-11-2695300 ext 170
+94 777766595
pujitha@pdt.cmb.ac.lk
Contact Person for Public Queries
Vithanage Pujitha Wickramasinghe
Senior Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 00800, Sri Lanka
+94-11-2695300 ext 170
+94 777766595
pujitha@pdt.cmb.ac.lk
Primary study sponsor/organization
Dept of Paediatrics, Faculty of Medicine, University of Colombo in collaboration with IBMBB of University of Colombo
Faculty of Medicine, University of Colombo in collaboration with Institute of Biochemistry, Molecular Biology and Biotechnology of University of Colombo
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
After de-identification of individual participants data that underlie the results that are being published/reported will be shared. In addition, study protocol and statistical analytical methods will be available. Data will be available once data has been published for the scientific community. Data will be shared with any person on who needs to access to the data. Data will be used for any form of purpose that data would be useful for. Data will be made be accessible when a formal request to be made to pujitha@pdt.cmb.ac.lk and required data fields will be shared.
Study protocol available
No
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
