Vitamin D Deficiency in Adults Following a Major Burn Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System-29
研究概览
简要总结
This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily). Capsules will be made in a compounding pharmacy and will look identical.
Randomized controlled trial. People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D. Treatment arm is high dose Vitamin D (4000 IU), and control is low dose Vitamin D (400 IU). Main outcome variables include PROMIS-29 measures of physical health, mental health and social health, the Veterans RAND 12 Item Health Survey (VR-12), and the 4-D Itch Scale. Secondary outcome variables include subject demographics, injury demographics and characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18 years of age or older, who have completed 6 months from time of their burn injury
- •≥ 10% TBSA, ≥ 65 years of age and Burn Surgery for Wound Closure
- •≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure
- •Electrical high voltage / lightning and Burn Surgery for Wound Closure
- •Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure
- •May speak English or Spanish
- •Vit. D deficiency
排除标准
- •Patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury
- •Patients with malignant tumors
- •Patients not meeting the inclusion criteria
研究组 & 干预措施
Low-dose
400 IU Per Orem
干预措施: Ergocalciferol Capsules (Drug)
High-dose
4000 IU Per Orem
干预措施: Ergocalciferol Capsules (Drug)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System-29
时间窗: 6 months and 12 months
Measures change in physical health, mental health and social health between time points. When the scores are transformed into t-score metric, all PROMIS measures range from 0-100. For each domain, the higher scores indicate more of what is being measured. Therefore, higher scores on anxiety indicate more anxiety, while higher scores on physical function indicate higher physical function. Please see more information here: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis.
次要结局
- Demographics(6 months)
- Patient-Reported Outcomes Measurement Information System-Global(6 months and 12 months)
- Patient-Reported Outcomes Measurement Information System-Itch(6 months and 12 months)
研究者
Karen Kowalske
Professor
University of Texas Southwestern Medical Center