The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates (VitD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates|
- Healed fracture [ Time Frame: up to 15 months post-surgery ] [ Designated as safety issue: No ]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.
- Nonunion [ Time Frame: 6-15 months post-injury ] [ Designated as safety issue: No ]
A fracture will be considered to result in nonunion when:
- 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.
- 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
- 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.
- Lost to Follow-Up [ Time Frame: up to 15 months post-surgery ] [ Designated as safety issue: No ]Patients will be deemed lost-to-follow-up if they have not yet met the criteria for healed fracture or nonunion and their last follow-up visit is <9 months and >15 months post-surgery (or post-injury for nonoperatively treated patients). This gives them a 6 month window for a final follow-up appointment and 9 months to attempt to heal the fracture. (If indefinite follow-up were allowed, then patients earlier in the study would have more time for follow-up, which may confound the data.) Data from patients who are lost-to-follow-up will be excluded from the final analysis. Patients who follow-up between 9 and 15 months will be included in the analysis regardless of prior compliance with follow-up.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.
Dietary Supplement: Vitamin D
Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.
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.
|United States, North Carolina|
|Carolinas Medical Center||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Rachel Seymour, PhD 704-355-6969 Rachel.Seymour@carolinashealthcare.org|
|Contact: Christine Churchill, BA 704-355-6947 Christine.Churchill@carolinashealthcare.org|
|Principal Investigator: Madhav Karunakar, MD|
|Principal Investigator:||Madhav Karunakar, MD||Carolinas Healthcare System|
|Study Director:||Rachel Seymour, PhD||Carolinas Healthcare System|
|Study Chair:||Christine Churchill, BA||Carolinas Healthcare System|