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

NCT ID: NCT01691833

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Hypovitaminosis D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Normovitaminosis

Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madhav Karunakar, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Rachel Seymour, PhD

Role: STUDY_DIRECTOR

Wake Forest University Health Sciences

Christine Churchill, MA

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

01-11-09A

Identifier Type: -

Identifier Source: org_study_id