Vitamin D Supplement for Patients With Tibial Fracture

Northern Orthopaedic Division, Denmark

Status and phase: Unknown; Phase 1

Conditions: Tibial Fracture

Treatments: Drug: Placebo orally everyday; Drug: Vitamin D3 cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01955577

N-20130033

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

Vitamin D3 cholecalciferol

Experimental group

Description:

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

Treatment:

Drug: Vitamin D3 cholecalciferol

Placebo orally everyday

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo orally everyday