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
Phase 4
- Conditions
- Dengue fever
- Registration Number
- SLCTR/2023/007
- Lead Sponsor
- Dept of Paediatrics, Faculty of Medicine, University of Colombo in collaboration with IBMBB of University of Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * Duration of plasma leaking determined by the time from onset of leak to end of leak (end of leak determined by stabilizing vital signs, return of PCV to normal level, clinical improvement with splitting of second heart sounds (S2) and diuresis) <br><br>• 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]<br>
- Secondary Outcome Measures
Name Time Method * Duration of hospital stay. <br><br>* Platelet count, WBC count and Hematocrit from Day 3 to Day 7 of illness <br><br>• AST, ALT, serum albumin, bilirubin, serum calcium and uric acid from Day 3 to Day 7 of illness <br><br>• TEAC (Trolox Equivalent Antioxidant Capacity), ABTS (2,2-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) from Day 3 to Day 7 of illness <br><br>• Transferring to the ICU needed or not<br><br> [Daily from 2nd to 7th day of illness (from beginning of fever- during hospital stay) and at 10-14 days of illness]<br>