CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Vitamin D +1 moredietary
Likely dose
Vitamin D 10,000 IU (dose form/frequency not specified)AI-extracted
Key inclusion· 3
  • Presence of a long bone fracture (humerus, femur, or tibia)
  • Age ≥18 years
  • Ability to follow-up at clinic for 12 months
Key exclusion· 8
  • Pathologic fractures (e.g., from tumor, cyst, or Paget's disease)
  • Open fractures of Gustilo-Anderson type IIIB or C
  • Multiple fractures
  • Presentation delay >2 weeks from time of injury

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01691833
NCT01691833N/ACompleted

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

Wake Forest University Health Sciences·interventional·Posted Sep 25, 2012·Updated Jul 14, 2022

In Brief

A clinical study evaluating Vitamin D and Placebo for Hypovitaminosis D. Completed, enrolled 113 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2012
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.8 years ago

Interventions

Vitamin Ddietary

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

Placebodietary

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