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

Wake Forest University (WFU)

Status: Completed

Conditions: Hypovitaminosis D

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01691833

01-11-09A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 3 patient groups, including a placebo group

Vitamin D

Experimental group

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.

Treatment:

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Placebo

Normovitaminosis

No Intervention group

Description:

Patients with normovitaminosis( levels greater than or equal to 30ng/ml) will receive no intervention.