Vitamin E Supplementation in Burned Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Plasma Alpha- and Gamma-Tocopherol
研究概览
简要总结
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.
详细描述
Please see above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 16 - 85 years
- •≥40% total body surface area burn
排除标准
- •Septic shock
- •Bleeding disorders
- •Diabetes, or on diabetes medications or anti-lipidemic agents
- •Arthritis
- •Known kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis, liver disease
- •Congestive heart failure
- •Positive hepatitis or HIV screens
- •Pregnancy (women)
研究组 & 干预措施
Early Vitamin E
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
干预措施: Vitamin E (Drug)
Delayed Vitamin E
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
干预措施: Vitamin E (Drug)
结局指标
主要结局
Plasma Alpha- and Gamma-Tocopherol
时间窗: Days 0-30
Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status
Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels
时间窗: Days 0-30
Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.
次要结局
- Exercise Stress Test(Day 30)
- Wound Healing(Days 0-30)
- Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites(Days 0-30)
- Adipose Alpha- and Gamma-Tocopherol(Days 0-30)
- Pulmonary Function Testing(Day 30)
- Number of Participants Completing Pulmonary Function Testing(Day 30)
- Number of Participants Assessed for Plasma and Urine Oxidative Stress and Vitamin E Metabolite Biomarkers(Days 0-30)
- Number of Participants Assessed for Adipose Alpha- and Gamma-Tocopherol Concentrations(Days 0-30)