Vitamin D Supplement for Patients With Tibial Fracture

Tibial Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01955577
• Other study ID #: N-20130033
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 24, 2013
• Last updated: April 9, 2015
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: Christian Cavallius, M.D.
• Email: christian.cavallius[@]rn.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Drug:
• Placebo orally everyday

• Vitamin D3 cholecalciferol

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of fracture healing	Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.	20 weeks	No
Secondary	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	No
Secondary	Complications	Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery.	20 weeks	No