Clinical trial NCT01691833: The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
Official title: The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovitaminosis D
Keywords: Vitamin D
nonunion
long bone fracture
hypovitaminosis D
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fracture Union
timeFrame: up to 9 months post-surgery
measure: Fracture Non-union
timeFrame: 9 months
Secondary outcomes:
measure: Fixation Failure
timeFrame: three months
measure: Deep Infection
timeFrame: 15 months
measure: Lost to Follow-up
timeFrame: 15 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Madhav Karunakar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Rachel Seymour, PhD
role: STUDY_DIRECTOR
affiliation: Wake Forest University Health Sciences
name: Christine Churchill, MA
role: STUDY_CHAIR
References: