NCT07006714进行中（未招募）4 期
Preoperative Single High-Dose Vitamin D for Correcting Deficiency in Hip and Knee Arthroplasty Patients-A Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prosthetic joint infection as measured by the Musculoskeletal Infection Society (MSIS) criteria.
研究概览
简要总结
The purpose of this study is being conducted to determine whether correcting low levels of vitamin D with a single high-dose supplement reduces complications after the participant's primary TJA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 96 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum 25(OH)D < 30 ng/mL within 2 weeks of surgery.
- •Able to provide informed consent.
排除标准
- •Follow-up duration < 90 days anticipated.
- •Acute hepatitis, cancer, organ transplant recipients, or dialysis patients.
- •Extra vitamin D supplementation within 90 days post-surgery.
- •Preoperative serum 25(OH)D ≥ 30 ng/mL.
- •Adults unable to consent (excluded).
- •Individuals under 18 (excluded).
- •Pregnant women (excluded).
- •Prisoners (excluded).
研究组 & 干预措施
Vitamin D Deficient Group
Experimental
Participants who are vitamin D deficient and undergo standard of care TJA will receive a single dose of vitamin D. Total participation for up to 90 days.
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Prosthetic joint infection as measured by the Musculoskeletal Infection Society (MSIS) criteria.
时间窗: Up to 90 days.
The MSIS criteria infection scores range from 0-1 as not infected, 2-5 as possibly infected, and 6 or greater than 6 as infected.
次要结局
- Hospital length of stay(Up to 90 days.)
- Number of medical complications(Up to 90 days.)
- Number of readmission rates(Up to 90 days.)
研究者
Michele D'Apuzzo
Assistant Professor
University of Miami
研究点 (1)
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