Vitamin D Supplement for Patients With Tibial Fracture

Phase 1

• Conditions: Tibial Fracture
• Interventions: Drug: Vitamin D3 cholecalciferol; Drug: Placebo orally everyday

• Registration Number: NCT01955577
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief 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.

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-10-07
• Status Verified: 2015-04
• Study Start: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 cholecalciferol	Vitamin D3 cholecalciferol	1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.
Placebo orally everyday	Placebo orally everyday	One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.

Primary Outcome Measures

Name	Time	Method
Time of fracture healing	20 weeks	Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.

Secondary Outcome Measures

Name	Time	Method
Vitamin D receptor DNA	20 weeks	A DNA blood sample will be taken in order to analyse how the skeleton reacts on vitamin D supplement.
Complications	20 weeks	Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Region Northern Jutland, Denmark