Clinical Trial: The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

Brief Summary: The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.

Detailed Summary: Vitamin D plays an important role in maintaining calcium and phosphate balance in the body and is important for maintenance of bone formation, remodeling, and healing. An extensive literature search indicates that although there is evidence that vitamin D deficiency is associated with fracture risk, there is no evidence of the role of vitamin D deficiency in subsequent failure to heal. This study aims to determine whether the relationship of vitamin D deficiency to nonunion is clinically relevant by showing whether its treatment can decrease the risk of nonunion. We will determine the incidence of nonunion in patients with untreated hypovitaminosis D and calculate the relative and absolute risk reductions for nonunion with normal vitamin D levels compared to untreated hypovitaminosis D. We will also calculate the relative and absolute risk reductions for nonunion with hypovitaminosis D treated with vitamin D supplementation compared to placebo.
Sponsor: Carolinas Healthcare System

Current Primary Outcome: Healed fracture [ Time Frame: up to 15 months post-surgery ]

A fracture will be considered healed if (1) the patient follows-up at any time prior to 15 months post-surgery (post-injury for nonoperatively treated patients), (2) the patient has no tenderness to palpation at the fracture site, AND (3) a group of 3 independent reviewing orthopaedic surgeons agree that it is healed based on the most recent radiographs and any other available imaging studies.


Original Primary Outcome: Same as current

Current Secondary Outcome: Nonunion [ Time Frame: 6-15 months post-injury ]

A fracture will be considered to result in nonunion when:

  1. A group of 3 independent reviewing orthopaedic surgeons agree that a nonunion has resulted based on the earliest 9 to 15-month follow-up radiographs and other prior imaging studies.
  2. At a follow-up of >6 months, a group of 3 independent reviewing orthopaedic surgeons agree that there has been regression or no progression of healing on serial radiographs for at least 3 months. (11) OR
  3. The patient is taken to the operating room to undergo a procedure based on a diagnosis of nonunion. No independent radiograph review is necessary. This does not include delayed operative intervention based on a trial of nonoperative treatment with patient dissatisfaction (e.g. due to continued pain or malalignment). Such patients will be analyzed with their follow-up time from the time of operation.


Original Secondary Outcome: Same as current

Information By: Carolinas Healthcare System

Dates:
Date Received: September 17, 2012
Date Started: February 2011
Date Completion: December 2017
Last Updated: February 24, 2017
Last Verified: February 2017