Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
130 participants
INTERVENTIONAL
2015-04-30
2016-12-31
Brief Summary
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1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator
2. if vitamin D supplement facilitates fracture healing
3. a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vitamin D3 cholecalciferol
1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.
Vitamin D3 cholecalciferol
Placebo orally everyday
One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.
Placebo orally everyday
Interventions
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Placebo orally everyday
Vitamin D3 cholecalciferol
Eligibility Criteria
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Inclusion Criteria
* A written signed statement of consent
* All potential patients primary with osteosynthesis Iliazov
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Northern Orthopaedic Division, Denmark
OTHER
Responsible Party
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Principal Investigators
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Tine L. Bennedsen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital, Denmark
Locations
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Aalborg University Hospital
Aalborg, Region Northern Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N-20130033
Identifier Type: -
Identifier Source: org_study_id
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