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Vitamin D Supplement for Patients With Tibial Fracture

Primary Purpose

Tibial Fracture

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Placebo orally everyday
Vitamin D3 cholecalciferol
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fracture focused on measuring Vitamin D deficiency, Ring fixator, Tibial fracture

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 cholecalciferol

Placebo orally everyday

Arm Description

1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.

One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2013
Last Updated
April 9, 2015
Sponsor
Northern Orthopaedic Division, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01955577
Brief Title
Vitamin D Supplement for Patients With Tibial Fracture
Official Title
Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose is to study: the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator if vitamin D supplement facilitates fracture healing 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fracture
Keywords
Vitamin D deficiency, Ring fixator, Tibial fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 cholecalciferol
Arm Type
Experimental
Arm Description
1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.
Arm Title
Placebo orally everyday
Arm Type
Placebo Comparator
Arm Description
One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.
Intervention Type
Drug
Intervention Name(s)
Placebo orally everyday
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 cholecalciferol
Primary Outcome Measure Information:
Title
Time of fracture healing
Description
Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Vitamin D receptor DNA
Description
A DNA blood sample will be taken in order to analyse how the skeleton reacts on vitamin D supplement.
Time Frame
20 weeks
Title
Complications
Description
Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Cavallius, M.D.
Email
christian.cavallius@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Juozas Petruskevicius, M.D., Ph.D.
Phone
99 32 52 40
Ext
45
Email
juope@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine L. Bennedsen, M.D.
Organizational Affiliation
Aalborg University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
Region Northern Jutland
ZIP/Postal Code
9000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tine L. Bennedsen, M.D.
Phone
99 32 63 46
Ext
45
Email
tilb@rn.dk
First Name & Middle Initial & Last Name & Degree
Juozas Petruskevicius, M.D., Ph.d.
Phone
99 32 52 40
Ext
45
Email
juope@rn.dk
First Name & Middle Initial & Last Name & Degree
Christian Cavallius, M.D.
First Name & Middle Initial & Last Name & Degree
Juozas Petruskevicius, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Matthias Steinbauer, M.D.
First Name & Middle Initial & Last Name & Degree
Torleif Trydal, M.D.
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, M.D.

12. IPD Sharing Statement

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Vitamin D Supplement for Patients With Tibial Fracture

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