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

Recruiting in Palo Alto (17 mi)

Overseen byMadhav Karunakar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Treatment Details

Interventions

Placebo (Placebo)
Vitamin D (Vitamin Supplement)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Vitamin DExperimental Treatment1 Intervention

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.

Group II: NormovitaminosisActive Control1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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.

Vitamin D is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vitamin D for: