Longitudinal Study of Patients Following Long Bone Fracture

Vitamin D Clinical Trial

Official title:

Longitudinal Study of Vitamin D Metabolism and Bone Healing in Adult Patients With Recent Long Bone Fracture

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

• Fractures, Bone
• Long Bone Fracture
• Vitamin D

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