Longitudinal Study of Patients Following Long Bone Fracture
Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture
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
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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London, 영국, E1 1BB
- The Royal London Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Long bone fracture
Patients presenting to accident and emergency during the study period with long bone or clavicle fracture
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개입 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
기간: 5-14 days post fracture
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5-14 days post fracture
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2차 결과 측정
결과 측정 |
기간 |
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Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing
기간: Baseline, 5-14 days, and 4-10 weeks post fracture
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Baseline, 5-14 days, and 4-10 weeks post fracture
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Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.
기간: Baseline, 5-14 days, and 4-10 weeks post fracture
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Baseline, 5-14 days, and 4-10 weeks post fracture
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Adrian Martineau, MRCP, Queen Mary University of London
- 수석 연구원: Tim Harris, BM BS, Barts and the London NHS Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .