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

NCT01691833 | Completed Results DMC

• 1 other identifier: 01-11-09A
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D

Keywords

Vitamin D; nonunion; long bone fracture; hypovitaminosis D

Outcome Measures

Primary Outcomes (2)

• Fracture Union

  Fracture Union is define as either clinical or radiological union. Clinical union defined as the absence of pain at the fracture site with the ability to bear full weight on the extremity without pain for activities of daily living (ambulation, lifting, carrying). Radiological union was determined by two blinded, independent review-ers and defined as the presence of bridging callus across at least three of four cortices or two of four cortices with a stable implant. When discrepancies between clinical and radiological union arose, the clinical assessment of union was preferred. Discrepancies in radiological outcomes were re-examined and a consensus view was obtained between reviewers if needed, to determine the outcome.If a patient did not meet the criteria for union and had at least nine months of follow•up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.

  up to 9 months post-surgery

• Fracture Non-union

  If a patient did not meet the criteria for union and had at least nine months of follow-up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.

  9 months

Secondary Outcomes (3)

• Fixation Failure

  three months

• Deep Infection

  15 months

• Lost to Follow-up

  15 months

Study Arms (3)

Vitamin D

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.

Dietary Supplement: Vitamin D

Placebo

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.

Dietary Supplement: Placebo

Normovitaminosis

NO INTERVENTION

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

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Vitamin D

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Rachel Seymour
• Organization: Carolinas Healthcare System

Rachel.Seymour@carolinas.org

704-355-2000

Study Officials

• Madhav Karunakar, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Rachel Seymour, PhD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

• Christine Churchill, MA

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 25, 2012
• Study Start: February 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 14, 2022
• Results First Posted: February 15, 2019

Record last verified: 2018-10

Locations

US (1)