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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2023/007

Enrollment

Unknown

Registered

2023-04-03

Start date

2023-04-04

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue fever

Interventions

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 rece

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
* 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) • 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]	—

Measure

Time frame

* 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) • 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

Measure	Time frame
* Duration of hospital stay. * Platelet count, WBC count and Hematocrit from Day 3 to Day 7 of illness • 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]	—

Measure

Time frame

* Duration of hospital stay. * Platelet count, WBC count and Hematocrit from Day 3 to Day 7 of illness • 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]

—

Countries

Sri Lanka

Contacts

Public ContactVithanage Pujitha Wickramasinghe

Senior Professor in Paediatrics

pujitha@pdt.cmb.ac.lk+94-11-2695300 ext 170

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026