A Phase 1 interventional study of Placebo orally everyday and Vitamin D3 cholecalciferol in Tibial Fracture, sponsored by Northern Orthopaedic Division, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Northern Orthopaedic Division, Denmark · Phase 1, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 130 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.
Drug: Vitamin D3 cholecalciferol
One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.
Drug: Placebo orally everyday
Time of fracture healing
Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.
Time frame: 20 weeks
Vitamin D receptor DNA
A DNA blood sample will be taken in order to analyse how the skeleton reacts on vitamin D supplement.
Time frame: 20 weeks
Complications
Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery.
Time frame: 20 weeks
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark