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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170572
Other study ID # 007076
Secondary ID 10/H0805/6
Status Completed
Phase N/A
First received July 26, 2010
Last updated November 6, 2012
Start date March 2010
Est. completion date October 2010

Study information

Verified date November 2012
Source Barts & The London NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

1. Any cross-shaft long bone or clavicle fracture within last 12 hours

2. Able to give written informed consent

3. Age = 16 years

4. Fused physes (physiologically adult)

Exclusion Criteria:

1. Taking medication affecting vitamin D metabolism - carbamazepine, phenobarbital, phenytoin or primidone

2. Taking vitamin D supplement > 800 IU/day

3. Abdominal visceral injury, pleural injury (except pneumothorax), spinal cord injury, or GCS < 15 at presentation to hospital

4. Known Paget's disease, osteopetrosis, metastatic bone cancer, or primary bone cancer

5. Current prisoners

6. Currently taking part in another clinical research project

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
United Kingdom The Royal London Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Barts & The London NHS Trust London Deanery

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline. 5-14 days post fracture No
Secondary 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 No
Secondary Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway. Baseline, 5-14 days, and 4-10 weeks post fracture No
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