The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
This trial is active, not recruiting.
|Treatments||vitamin d, placebo|
|Sponsor||Carolinas Healthcare System|
|Start date||February 2011|
|End date||January 2017|
|Trial size||880 participants|
|Trial identifier||NCT01691833, 01-11-09A|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
time frame: up to 15 months post-surgery
time frame: 6-15 months post-injury
Male or female participants at least 18 years old.
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
|Official title||The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates|
|Principal investigator||Madhav Karunakar, MD|
|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.|
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