NCT01955577

Vitamin D Supplement for Patients With Tibial Fracture

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Northern Orthopaedic Division, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to study: 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

Detailed description

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.

Conditions

• Tibial Fracture

Interventions

Type	Name	Description
DRUG	Placebo orally everyday
DRUG	Vitamin D3 cholecalciferol

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-10-07
• Last updated: 2015-04-10

Locations

1 site across 1 country: Denmark