Home » Trials » SLCTR/2025/009
Assessment of the effect of vitamin E supplementation on oxidative stress levels in children infected with dengue virus in Sri Lanka
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SLCTR Registration Number
SLCTR/2025/009
Date of Registration
The date of last modification
Mar 06, 2025
Scientific Title of Trial
Assessment of the effect of vitamin E supplementation on oxidative stress levels in children infected with dengue virus in Sri Lanka
Public Title of Trial
A controlled clinical trial on the effect of Vitamin E Supplementation on oxidative stress levels compared to standard treatment in 5-14 year old children infected with dengue virus in Sri Lanka:
Disease or Health Condition(s) Studied
Dengue
Scientific Acronym
Public Acronym
Brief title
Controlled clinical trial on assessing the effect of vitamin E supplementation on oxidative stress levels in 5-14 year old children infected with dengue virus at the Lady Ridgeway Hospital for Children Colombo Sri Lanka.
Universal Trial Number
U1111-1318-6860
Any other number(s) assigned to the trial and issuing authority
EC-24-134 (Faculty of Medicine, Colombo)
What is the research question being addressed?
In Sri Lankan children aged 5-14 years infected with dengue virus, how does vitamin E supplementation compared to no supplementation influence antioxidant status, biochemical parameters, clinical outcomes, and the progression of antioxidant status across the critical, convalescent, and febrile stages of infection?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Phase 2-3
Intervention(s) planned
The study will be conducted on Professorial Paediatric Unit (giving vitamin E) and Ward 4 (control). Both are General Paediatric medical ward at the Lady Ridgway Hospital for Children Colombo (LRH). All the children enrolled in the study will receive standard care according to the national guidelines for Dengue management. The children in the control group will not receive vitamin E supplementation. Those in the Vitamin E supplemented arm will receive 200 mg per day if the child is below 8 years old and 400mg per day if the child is 8 years to 14 years old upon admission. Vitamin E will be supplemented until the 7th day of admission.
Inclusion criteria
Children between the ages of 5–14 years within first 84 hours of onset of fever, in whom dengue infection is clinically suspected or immunologically diagnosed (NS1 positive). Clinical suspicion is made based on along with 2 of the other clinical symptoms: headache, retro-orbital pain, myalgia, arthralgia, bone pain, leucopaenia (WBC count <5.0 × 109 /L), thrombocytopenia (platelet count less than 150 × 109 /L) and rising hematocrit (>10% above baseline) as described by the national guidelines published by Ministry of Health Sri Lanka
Exclusion criteria
Any child on long-term medication, underlying chronic illness such as cardiac, renal or hepatic disease and those taking vitamin supplements.
Primary outcome(s)
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1.
Serum Total Antioxidant Capacity - Measured using the ABTS assay. The ABTS assay is a colorimetric assay that measures the antioxidant capacity of a substance. The antioxidant levels will be determined using the calibration curve of Trolox and results are expressed as Trolox Equivalent Antioxidant Capacity (TEAC). |
[ Serum samples will be analyzed daily from day of admission to discharge (day 7) to investigate how the antioxidant capacity varies during different stages of the infection. Serum will also be analyzed on day 14 of convalescence stage ] |
Secondary outcome(s)
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1.
Serum Bilirubin- Diazo method – manually performed using colorimetric assay kit |
[ Serum samples will be analyzed daily from day of admission to discharge (day 7) to investigate the variations of the serum antioxidant bilirubin during different stages of the infection. ] |
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2.
Serum Uric acid - Uricase method- manually performed using colorimetric assay kit |
[ Serum samples will be analyzed daily from day of admission to discharge (day 7) to investigate the variations of the serum antioxidant uric acid during different stages of the infection. ] |
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3.
Serum albumin - Bromocresol Green Method (BCG) manually performed using colorimetric assay kit |
[ Serum samples will be analyzed daily from day of admission to discharge (day 7) to investigate the variations of the serum antioxidant albumin during different stages of the infection. ] |
Target number/sample size
90 ( 45 subjects in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-03-15
Anticipated end date
2025-09-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2024-11-21
Approval number
EC-24-134
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Colombo. |
| Institutional Address: | Ethics Review Committee Faculty of Medicine University of Colombo P O Box 271, Kynsey Road, Colombo 8, Sri Lanka |
| Telephone: | +94-11-2695300 |
| 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
P O Box 271, Kynsey Road, Colombo 8, Sri Lanka
+94112688748
+94777766595
pujithaw@yahoo.com
Contact Person for Public Queries
Prof. V. Pujitha Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo
P O Box 271, Kynsey Road, Colombo 8, Sri Lanka
+94112688748
+94777766595
pujithaw@yahoo.com
Primary study sponsor/organization
Professor Sharmila Jayasena
Head of the Department
Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo
+94 112629774 Ext – 1718
sharmila@bmb.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
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
