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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
London, Det Forenede Kongerige, E1 1BB
- The Royal London Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Long bone fracture
Patients presenting to accident and emergency during the study period with long bone or clavicle fracture
|
Ingen indgriben
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
Tidsramme: 5-14 days post fracture
|
5-14 days post fracture
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing
Tidsramme: 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.
Tidsramme: Baseline, 5-14 days, and 4-10 weeks post fracture
|
Baseline, 5-14 days, and 4-10 weeks post fracture
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Adrian Martineau, MRCP, Queen Mary University of London
- Ledende efterforsker: Tim Harris, BM BS, Barts and the London NHS Trust
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 007076
- 10/H0805/6 (Anden identifikator: REC number)
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