N/A
N=113
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
Hypovitaminosis D
Bottom Line
View on ClinicalTrials.gov: NCT01691833 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Fracture Union — 40; 39; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fracture Union |
40; 39; 10 | — |
| PRIMARY Fracture Non-union |
2; 2; 3 | — |
| SECONDARY Fixation Failure |
1; 1; 0 | — |
| SECONDARY Deep Infection |
0; 1; 0 | — |
| SECONDARY Lost to Follow-up |
7; 7; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01691833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.