The influence of the initial vitamin D status on the fracture consolidation will be studied. These study results might give rise to a randomised controles trial with vitamin D supplementation in order to investigate the effect of supplementation on…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delayed union, defined as incomplete consolidation (clinically and
radiologically) after 4 months.
Secondary outcome
- Non-union, defined as absent fracture consolidation after 9 months
- Complications during fracture healing (infection, mal-Union, refracture,
(re)operation).
- Perceived pain
- Functional recovery
- Quality of life
- Costs.
- Natrium, potasium, kreatinin, calcium, phosfor, PTH, alkaline phosphatase,
CTX en PINP
Background summary
A large part of the population has a relative or absolute vitamin D deficiency.
Resent unpublished results show that 70% of the patient population between 18
and 50 years with a fracture has a vitamin D insufficiency (25 (OH) D <75 nmol
/ L), and 40% has a deficiency (25 (OH) D <50 nmol / L). Vitamin D plays a
important role in the cellular process of fracture healing. However, the number
of available clinical studies on the role of vitamin D on fracture healing is
scarce and these studies mainly focus on elderly fracture patients. The
clinical effect of vitamin D status and vitamin D supplementation on fracture
healing is unknown in the fracture population aged between 18 and 50 years.
Study objective
The influence of the initial vitamin D status on the fracture consolidation
will be studied. These study results might give rise to a randomised controles
trial with vitamin D supplementation in order to investigate the effect of
supplementation on fracture healing. Primarily, the effect of vitamin D status
on bone healing, the incidence of delayed fracture healing (delayed union) will
be investigated. Secondary the effect of vitamin D status on the occurrence of
complications , functional outcome, and health-related quality of life will be
investigated. We will also examine the influence of the initial vitamin D
status on the fracture healing, and conduct a costanalysis on vitamin D status.
Study design
In this prospective cohort study, patients will be seen according to a fixed
schedule during which fracture healing will be monitored using radiography, and
blood samples will be obtained for determination of the vitamin D status and
biomarkers for fracture healing.
Study burden and risks
Participation in the study involves more time for the patient (1-2 additional
visits to the outpatient clinic, filling out questionnaires). Also blood
samples will be obtained three times during the study. The X-rays
investigations are standard treatment practice. The risk of participation is
minimal since it is a relatively young patient population, in whom normally
vitamin D is not determined or administered.
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Age 18 -50 years
- Extra-articular fracture of the clavicle, humerus, fore arm, metacarpalia, femur, lower leg or metatarsalia.
- Initial X-ray;s
- Inclusion within 10 days after trauma
Exclusion criteria
Refracture, pathological fracture, complicated fracture.
Use of vitamin D or glucocorticosteroids
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52965.058.15 |