Vitamin D Supplement for Patients With Tibial Fracture

Study Overview
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Brief Summary
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The purpose is to study: the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator if vitamin D supplement facilitates fracture healing a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing

Detailed Description
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External ring fixator is a widespread and well-known method to treate complex tibial fractures. The effect of treating proximal and distal intra-articulatio tibial fractures has been positive until now. Complications such as malunions, nonunions, re-fractures and extended time of ring fixation will occur in 5-10% of all tibial fractures in patients treated with ring fixator. Factors like trauma of soft tissue, smoking and compromised afflux of blood are associated with a higher frequency of nonunion. It has been documented that elderly people with hypovitaminosis D have a higher risk of being affected by osteoporosis and fractures. Furthermore, there is a possible association between the severity of fracture and hypovitaminosis. The time of fracture healing is also extended compared to fractures in patients who are not affected by osteoporosis. Until now research has not shown whether the fracture healing process is influenzed by vitamin D.

Official Title
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Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study.

Conditions
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Tibial Fracture

Intervention / Treatment
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* Drug: Placebo orally everyday
* Drug: Vitamin D3 cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with tibial fracture A written signed statement of consent All potential patients primary with osteosynthesis Iliazov Exclusion Criteria: Tumours in bone Metastases to bone marrow Chronic renal disease Drug abuse Abuse of alcohol (>21 drinks a week for men and > 14 drinks a week for women) Morbus Cushing disease Glandulae thyroid disease Pregnancy Chronic steroid therapy Hepatic insufficiency Sarcoidosis, tuberculosis or silocosis Patients under 18 years Inability to take medicine Adverse effects of vitamin D or allergic to vitamin D

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 cholecalciferol<br>1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily. | Drug: Vitamin D3 cholecalciferol<br> <br> |
| Placebo Comparator: Placebo orally everyday<br>One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily. | Drug: Placebo orally everyday<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of fracture healing | Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D receptor DNA | A DNA blood sample will be taken in order to analyse how the skeleton reacts on vitamin D supplement. | 20 weeks | 
| Complications | Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery. | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D deficiency, Ring fixator, Tibial fracture