Vitamin D Supplement for Patients With Tibial Fracture

NCT01955577 | Unknown Phase 1

• 1 other identifier: N-20130033
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to study:

1. 1.the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator
2. 2.if vitamin D supplement facilitates fracture healing
3. 3.a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing

Conditions

Tibial Fracture

Keywords

Vitamin D deficiency; Ring fixator; Tibial fracture

Outcome Measures

Primary Outcomes (1)

• Time of fracture healing

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

  20 weeks

Secondary Outcomes (2)

• Vitamin D receptor DNA

  20 weeks

• Complications

  20 weeks

Study Arms (2)

Vitamin D3 cholecalciferol

EXPERIMENTAL

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

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.

Drug: Placebo orally everyday

Interventions

Placebo orally everyday DRUG

Placebo orally everyday

Vitamin D3 cholecalciferol DRUG

Vitamin D3 cholecalciferol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with tibial fracture
• A written signed statement of consent
• All potential patients primary with osteosynthesis Iliazov

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Region Northern Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Tibial Fractures; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Tine L. Bennedsen, M.D.

  Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Cavallius, M.D.

CONTACT

christian.cavallius@rn.dk

Juozas Petruskevicius, M.D., Ph.D.

CONTACT

99 32 52 40; juope@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 7, 2013
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

DK (1)