An observational study in Vitamin D and Long Bone Fracture, sponsored by Barts & The London NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-11-07.
Sponsored by Barts & The London NHS Trust · Observational
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
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Barts & The London NHS Trust is the lead sponsor of 149 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the Accident and Emergency Department, Royal London Hospital, Whitechapel with a long bone or clavicle fracture
Exclusion Criteria:
Patients presenting to accident and emergency during the study period with long bone or clavicle fracture
Other: No intervention
No intervention
Serum concentration of 24,25-dihyroxyvitamin D at 5-14 days post cross sectional long bone or clavicle fracture, compared with baseline.
Time frame: 5-14 days post fracture
Serum concentrations of vitamin D metabolites (including 1,25-dihydroxyvitamin D and 25-hydroxyvitamin D) and markers of bone healing
Time frame: Baseline, 5-14 days, and 4-10 weeks post fracture
Peripheral blood expression of genes encoding enzymes in the vitamin D metabolic pathway.
Time frame: Baseline, 5-14 days, and 4-10 weeks post fracture
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Barts & The London NHS Trust