Tibial FracturePhase 1NCT01955577
Vitamin D Supplement for Patients With Tibial Fracture
A Phase 1 study testing Vitamin D3 cholecalciferol in people with Tibial Fracture, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Vitamin D3 cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with tibial fracture
- A written signed statement of consent
- All potential patients primary with osteosynthesis Iliazov
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Christian Cavallius, M.D. contact
Denmark1 site
Aalborg University Hospital
Aalborg, Region Northern Jutland, 9000
Tine L. Bennedsen, M.D., 99 32 63 46 ext. 45, tilb@rn.dk
Juozas Petruskevicius, M.D., Ph.d., 99 32 52 40 ext. 45, juope@rn.dk
About this study
Official title: 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:
- 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
Read the 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
- Being tested
- Placebo orally everyday, Vitamin D3 cholecalciferol
- Keywords
- Vitamin D deficiency, Ring fixator, Tibial fracture
- Medical subject headings
- Tibial Fractures, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo orally everydayDrug
Vitamin D3 cholecalciferolDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 cholecalciferol | Experimental | 1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily. Receives: Drug: Vitamin D3 cholecalciferol |
| Placebo orally everyday | Placebo comparator | One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily. Receives: Drug: Placebo orally everyday |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of fracture healing
Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.
Measured: 20 weeks
Secondary outcomes (2)
Vitamin D receptor DNA
A DNA blood sample will be taken in order to analyse how the skeleton reacts on vitamin D supplement.
Measured: 20 weeks
Complications
Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tine L. Bennedsen, M.D., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955577
- Sponsor's protocol ID
- N-20130033
- Status last verified
- Apr 2015
- First submitted
- 24 Sep 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study.
- ClinicalTrials.gov ID
- NCT01955577
- Acronym / sponsor ID
- N-20130033
- Conditions
- Tibial Fracture
- Keywords
- Vitamin D deficiency, Ring fixator, Tibial fracture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 cholecalciferol | Experimental | Drug: Vitamin D3 cholecalciferol1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily. |
| Placebo orally everyday | Placebo comparator | Drug: Placebo orally everydayOne placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with tibial fracture
- A written signed statement of consent
- All potential patients primary with osteosynthesis Iliazov
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo orally everyday | Drug | Placebo orally everyday |
| Vitamin D3 cholecalciferol | Drug | Vitamin D3 cholecalciferol |
Primary outcome
Time of fracture healing
Time frame: 20 weeks
Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.
2 secondary outcomes
Vitamin D receptor DNA
Time frame: 20 weeks
Complications
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Cavallius, M.D. contact
Tine L. Bennedsen, M.D. principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 cholecalciferol in people with Tibial Fracture, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Cavallius, M.D. (christian.cavallius@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of fracture healing (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.