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
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
London、イギリス、E1 1BB
- The Royal London Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Long bone fracture
Patients presenting to accident and emergency during the study period with long bone or clavicle fracture
|
介入なし
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
時間枠:5-14 days post fracture
|
5-14 days post fracture
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing
時間枠:Baseline, 5-14 days, and 4-10 weeks post fracture
|
Baseline, 5-14 days, and 4-10 weeks post fracture
|
Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.
時間枠:Baseline, 5-14 days, and 4-10 weeks post fracture
|
Baseline, 5-14 days, and 4-10 weeks post fracture
|
協力者と研究者
協力者
捜査官
- スタディディレクター:Adrian Martineau, MRCP、Queen Mary University of London
- 主任研究者:Tim Harris, BM BS、Barts and The London NHS Trust
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
介入なしの臨床試験
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
-
University of MichiganNational Institute on Drug Abuse (NIDA)積極的、募集していない
-
University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
-
Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺