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

NCT01691833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2022-07-14

Study results available
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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.

Conditions

  • Hypovitaminosis D

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.

DIETARY_SUPPLEMENT

Placebo

Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Madhav Karunakar, MD · Wake Forest University Health Sciences

  • Rachel Seymour, PhD · Wake Forest University Health Sciences

  • Christine Churchill, MA · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2017-01-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691833 on ClinicalTrials.gov