NCT01691833

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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. The aims of study were to: 1) quantify the rate of hypovitaminosis D in an orthopedic trauma population in the Southeastern United States; 2) determine the rate of nonunion in vitamin D deficient patients, and 3) assess the feasibility of acute high-dose vitamin-D supplementation in hypovitaminosis D patients.

Conditions

• Hypovitaminosis D

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Placebo	Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Timeline

• Start date: 2011-02-01
• Primary completion: 2017-01-01
• Completion: 2017-12-01
• First posted: 2012-09-25
• Last updated: 2022-07-14
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States