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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Madhav Karunakar, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01691833
First received: September 17, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hypovitaminosis D
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Healed fracture [ Time Frame: up to 15 months post-surgery ] [ Designated as safety issue: No ]
    A fracture will be considered healed if (1) the patient follows-up at any time prior to 15 months post-surgery (post-injury for nonoperatively treated patients), (2) the patient has no tenderness to palpation at the fracture site, AND (3) a group of 3 independent reviewing orthopaedic surgeons agree that it is healed based on the most recent radiographs and any other available imaging studies.


Secondary Outcome Measures:
  • Nonunion [ Time Frame: 6-15 months post-injury ] [ Designated as safety issue: No ]

    A fracture will be considered to result in nonunion when:

    1. A group of 3 independent reviewing orthopaedic surgeons agree that a nonunion has resulted based on the earliest 9 to 15-month follow-up radiographs and other prior imaging studies.
    2. At a follow-up of >6 months, a group of 3 independent reviewing orthopaedic surgeons agree that there has been regression or no progression of healing on serial radiographs for at least 3 months. (11) OR
    3. The patient is taken to the operating room to undergo a procedure based on a diagnosis of nonunion. No independent radiograph review is necessary. This does not include delayed operative intervention based on a trial of nonoperative treatment with patient dissatisfaction (e.g. due to continued pain or malalignment). Such patients will be analyzed with their follow-up time from the time of operation.


Other Outcome Measures:
  • Lost to Follow-Up [ Time Frame: up to 15 months post-surgery ] [ Designated as safety issue: No ]
    Patients will be deemed lost-to-follow-up if they have not yet met the criteria for healed fracture or nonunion and their last follow-up visit is <9 months and >15 months post-surgery (or post-injury for nonoperatively treated patients). This gives them a 6 month window for a final follow-up appointment and 9 months to attempt to heal the fracture. (If indefinite follow-up were allowed, then patients earlier in the study would have more time for follow-up, which may confound the data.) Data from patients who are lost-to-follow-up will be excluded from the final analysis. Patients who follow-up between 9 and 15 months will be included in the analysis regardless of prior compliance with follow-up.


Estimated Enrollment: 880
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomized
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
Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of a diaphyseal (shaft of the bone) fracture of the 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691833

Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Madhav Karunakar, MD Carolinas Healthcare System
Study Director: Rachel Seymour, PhD Carolinas Healthcare System
Study Chair: Christine Churchill, BA Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: Madhav Karunakar, MD, Department of Orthopaedic Surgery, Carolinas Medical Center, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01691833     History of Changes
Other Study ID Numbers: 01-11-09A
Study First Received: September 17, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Vitamin D
nonunion
long bone fracture
hypovitaminosis D

Additional relevant MeSH terms:
Rickets
Fractures, Ununited
Vitamin D Deficiency
Avitaminosis
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2014