The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Fracture Union
研究概览
简要总结
The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.
详细描述
Vitamin D plays an important role in maintaining calcium and phosphate balance in the body and is important for maintenance of bone formation, remodeling, and healing. An extensive literature search indicates that although there is evidence that vitamin D deficiency is associated with fracture risk, there is no evidence of the role of vitamin D deficiency in subsequent failure to heal. The aims of study were to: 1) quantify the rate of hypovitaminosis D in an orthopedic trauma population in the Southeastern United States; 2) determine the rate of nonunion in vitamin D deficient patients, and 3) assess the feasibility of acute high-dose vitamin-D supplementation in hypovitaminosis D patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •presence of a long bone fracture (humerus, femur, or tibia)
- •age greater than or equal to 18 years
- •ability to follow-up at our clinic for 12 months
排除标准
- •pathologic fractures (i.e. occuring in the presence of abnormal bone such as a tumor, cyst, or Paget's disease)
- •open fractures (i.e. associated skin disruption) of Gustilo-Anderson type IIIB or C (i.e. significant soft-tissue and bone devitalization)
- •presence of multiple fractures
- •delay in presentation for initial treatment of more than 2 weeks from the time of injury
- •preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)
- •preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)
- •pregnant patients
- •patients who are unable to provide consent for the study
- •patients who are unable to swallow due to acuity of illness or physiologic reason
- •prisoners who are patients because of their vulnerable population and inability to follow-up
结局指标
主要结局
Fracture Union
时间窗: up to 9 months post-surgery
Fracture Union is define as either clinical or radiological union. Clinical union defined as the absence of pain at the fracture site with the ability to bear full weight on the extremity without pain for activities of daily living (ambulation, lifting, carrying). Radiological union was determined by two blinded, independent review-ers and defined as the presence of bridging callus across at least three of four cortices or two of four cortices with a stable implant. When discrepancies between clinical and radiological union arose, the clinical assessment of union was preferred. Discrepancies in radiological outcomes were re-examined and a consensus view was obtained between reviewers if needed, to determine the outcome.If a patient did not meet the criteria for union and had at least nine months of follow•up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.
Fracture Non-union
时间窗: 9 months
If a patient did not meet the criteria for union and had at least nine months of follow-up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.
次要结局
- Deep Infection(15 months)
- Lost to Follow-up(15 months)
- Fixation Failure(three months)