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.

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

Study Overview

• Status: Unknown
• Conditions: Tibial Fracture
• Intervention / Treatment: Drug: Vitamin D3 cholecalciferol; Drug: Placebo orally everyday

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Region Northern Jutland
    • Aalborg, Region Northern Jutland, Denmark, 9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin D3 cholecalciferol; 1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.	Drug: Vitamin D3 cholecalciferol
PLACEBO_COMPARATOR: Placebo orally everyday; One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.	Drug: Placebo orally everyday

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of fracture healing	Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications	Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery.	20 weeks

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Investigators: Principal Investigator: Tine L. Bennedsen, M.D., Aalborg University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 27, 2013
• First Posted (ESTIMATE): October 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Vitamin D deficiency; Tibial fracture; Ring fixator
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: N-20130033