NCT00536276已完成1 期
Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
研究概览
简要总结
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
详细描述
The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is > 6 months of age but < 19 years old
- •Burn injury > 30% total body surface area
- •Admitted to SHC within 4 days of injury
- •Attending physician decision that patient is likely to survive
- •Parents or legal guardian give informed consent along with assent of the child as applicable
排除标准
- •Attending physician decision that patient is not likely to survive
- •Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (>1000 IU/D)
结局指标
主要结局
Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
时间窗: During acute phase postburn
次要结局
- Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers(During acute phase postburn)
研究者
Michele Gottschlich
Director, Nutrition Services
Shriners Hospitals for Children
研究点 (2)
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