Overview

This trial is active, not recruiting.

Condition hypovitaminosis d
Treatments vitamin d, placebo
Sponsor Carolinas Healthcare System
Start date February 2011
End date January 2017
Trial size 880 participants
Trial identifier NCT01691833, 01-11-09A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
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.
vitamin d
Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.
(Placebo Comparator)
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.
placebo
Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Primary Outcomes

Measure
Healed fracture
time frame: up to 15 months post-surgery

Secondary Outcomes

Measure
Nonunion
time frame: 6-15 months post-injury

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - presence of a long bone fracture (humerus, femur, or tibia) - age greater than or equal to 18 years - ability to follow-up at our clinic for 12 months Exclusion Criteria: - pathologic fractures (i.e. occuring in the presence of abnormal bone such as a tumor, cyst, or Paget's disease) - open fractures (i.e. associated skin disruption) of Gustilo-Anderson type IIIB or C (i.e. significant soft-tissue and bone devitalization) - presence of multiple fractures - delay in presentation for initial treatment of more than 2 weeks from the time of injury - preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism) - preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption) - pregnant patients - patients who are unable to provide consent for the study - patients who are unable to swallow due to acuity of illness or physiologic reason - prisoners who are patients because of their vulnerable population and inability to follow-up

Additional Information

Official title The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
Principal investigator Madhav Karunakar, MD
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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Carolinas Healthcare System.