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The purpose is to study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 cholecalciferol | Experimental | 1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily. |
|
| Placebo orally everyday | Placebo Comparator | One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo orally everyday | Drug |
| ||
| Vitamin D3 cholecalciferol |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Cavallius, M.D. | Contact | christian.cavallius@rn.dk | ||
| Juozas Petruskevicius, M.D., Ph.D. | Contact | 99 32 52 40 | 45 | juope@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Tine L. Bennedsen, M.D. | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Region Northern Jutland | 9000 | Denmark |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D001361 | Avitaminosis |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
|
| 20 weeks |
| D003677 |
| Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |