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NCT01749371
Vitamin E Supplementation in Burned Patients
Phase 2/Phase 3 trial testing Vitamin E in Burn in 31 participants. Completed in 1 September 2017.
1 August 2017
Quick facts
| Lead sponsor | The University of Texas Medical Branch, Galveston |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 1 February 2013 |
| Primary completion | 1 August 2017 |
| Estimated completion | 1 September 2017 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Vitamin E (VITAMIN E) — full drug profile →
Conditions studied
- Burn — all drugs for Burn →
Sponsor
The University of Texas Medical Branch, Galveston
Who can join
Adults 16 to 85, any sex, with Burn. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Plasma Alpha- and Gamma-Tocopherol
Time frame: Days 0-30
Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status
Sponsor's own description
A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01749371
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06211478 — Role of Vitamin E in Gaucher Disease Patients · Phase 3 · completed
- NCT04801849 — Vitamin E Dosing Study · Phase 2 · completed
Other recruiting trials for Burn
Currently open trials in the same condition.
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- NCT06992895 — The Effect of Hologram Application on Pain, Anxiety, and Fear Levels in Children During Burn Dressing · NA · recruiting
- NCT07453927 — Blue Light for Donor Site Healing in Burn Patients · NA · recruiting
- NCT07025408 — Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns · Phase 2 · recruiting
Other The University of Texas Medical Branch, Galveston trials
Trials by the same sponsor.
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- NCT07203287 — Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease · Phase 4 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01749371 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston
- Last refreshed: 17 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01749371.
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