The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | February 2011 |
| End Date: | December 2017 |
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.
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.
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.
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.
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
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