The Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial

• Conditions: Vitamin D; Vitamin D deficiency; Vitamin D insufficiency; Vitamin D supplementation; Fracture healing; Delayed union.

• Registration Number: NL-OMON20608
• Lead Sponsor: eiden University Medical Center

Brief Summary

A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Age between 18 and 50 years
- Extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture)

Exclusion Criteria

- Refracture; pathologic fracture; complicated fracture; Injury severity Score > 16; pregnancy
- Growth hormone deficiency; Immune compromised, sarcoïdosis
- Use of: Vitamin D, corticosteroids, digoxin, calcium / bisfosfonate, phenobarbital, phenytoïn

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delayed union, defined as incomplete consolidation (clinically and radiologically) after 4 months.

Secondary Outcome Measures

Name	Time	Method
- Non-union, defined as absent fracture consolidation after 9 months<br>- Complications during fracture healing (infection, mal-Union, refracture, (re)operation).<br>- Perceived pain<br>- Functional recovery<br>- Quality of life <br>- Cost(effectiveness)