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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:

Assessment of the effect of vitamin E supplementation on oxidative stress levels in children infected with dengue virus in Sri Lanka

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2025/009
Enrollment
Unknown
Registered
2025-03-06
Start date
2025-03-15
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

Interventions

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). A

Sponsors

Professor Sharmila Jayasena
Lead Sponsor

Eligibility

Inclusion criteria

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 10% above baseline) as described by the national guidelines published by Ministry of Health Sri Lanka

Exclusion criteria

Exclusion criteria: Any child on long-term medication, underlying chronic illness such as cardiac, renal or hepatic disease and those taking vitamin supplements.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. ] 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. ] 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. ]

Countries

Sri Lanka

Contacts

Public ContactProf. V. Pujitha Wickramasinghe

Professor in Paediatrics

pujithaw@yahoo.com+94112688748

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026