Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
研究概览
简要总结
Studies in chickens show that blood levels of a particular form of vitamin D (called 24,25-dihydroxvitamin D) increase after bone fracture. Laboratory studies show that this form of vitamin D helps the bone healing process in chickens. The investigators want to find out whether blood levels of this form of vitamin D increase after bone fracture in humans. Previous research studies have not addressed this question. The results of this research could eventually lead to the development of new treatments to help bone healing after fracture.
Patients will be asked to take part in this study if they are aged 16 years or older and come to the Royal London Hospital with a broken bone in the arm or leg or collar bone (clavicle). They will be asked to give a 20ml (about 4 teaspoons) blood sample on three occasions: at the start of the study, at 5-14 days after the fracture; and at 4-10 weeks after the fracture. The rest of their normal care would not be affected. Follow-up blood samples will be timed to coincide with routine clinic visits which are scheduled as part of normal clinical care. Patients' vitamin D level will be measured as part of the study, and those who have a low vitamin D level will be informed about this, and advised about appropriate vitamin D supplementation. The investigators will let the patient or their GP know if any blood tests are abnormal
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any cross-shaft long bone or clavicle fracture within last 12 hours
- •Able to give written informed consent
- •Age ≥ 16 years
- •Fused physes (physiologically adult)
排除标准
- •Taking medication affecting vitamin D metabolism - carbamazepine, phenobarbital, phenytoin or primidone
- •Taking vitamin D supplement > 800 IU/day
- •Abdominal visceral injury, pleural injury (except pneumothorax), spinal cord injury, or GCS < 15 at presentation to hospital
- •Known Paget's disease, osteopetrosis, metastatic bone cancer, or primary bone cancer
- •Current prisoners
- •Currently taking part in another clinical research project
结局指标
主要结局
Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
时间窗: 5-14 days post fracture
次要结局
- Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.(Baseline, 5-14 days, and 4-10 weeks post fracture)
- Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing(Baseline, 5-14 days, and 4-10 weeks post fracture)