Back to resultsThe Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates (VitD)
Primary Purpose
Hypovitaminosis D
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypovitaminosis D focused on measuring Vitamin D, nonunion, long bone fracture, hypovitaminosis D
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
Sites / Locations
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Vitamin D
Placebo
Normovitaminosis
Arm Description
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.
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.
Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Fixation Failure
Early failure of fixation was defined as the need to revise the fixation within three months.
Deep Infection
A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia.
Lost to Follow-up
Lost to follow-up if they did not meet the criteria for an outcome by 15 months after injury or surgery; were without another scheduled follow-up appointment, could not be contacted or refused to return for evaluation or send alternate records when contacted.
Full Information
NCT ID
NCT01691833
First Posted
September 17, 2012
Last Updated
July 12, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01691833
Brief Title
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
Acronym
VitD
Official Title
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
Keywords
Vitamin D, nonunion, long bone fracture, hypovitaminosis D
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Normovitaminosis
Arm Type
No Intervention
Arm Description
Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Patients that are Vitamin D deficient maybe randomized to the placebo group D.
Primary Outcome Measure Information:
Title
Fracture Union
Description
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.
Time Frame
up to 9 months post-surgery
Title
Fracture Non-union
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Fixation Failure
Description
Early failure of fixation was defined as the need to revise the fixation within three months.
Time Frame
three months
Title
Deep Infection
Description
A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia.
Time Frame
15 months
Title
Lost to Follow-up
Description
Lost to follow-up if they did not meet the criteria for an outcome by 15 months after injury or surgery; were without another scheduled follow-up appointment, could not be contacted or refused to return for evaluation or send alternate records when contacted.
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhav Karunakar, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Seymour, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christine Churchill, MA
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
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