Clinical Trials Logo

Clinical Trial Summary

The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months.


Clinical Trial Description

Vitamin D supplements are increasingly being recommended to healthy adult fracture patients without an osteoporotic injury. Although this is a relatively new practice pattern, the basis for this adjunct therapy is grounded in the high hypovitaminosis D prevalence rates (up to 75%) among healthy adult fracture patients, and the strong biologic rationale for the role of vitamin D in fracture healing. Briefly, experimental animal studies have demonstrated that the concentration of vitamin D metabolites is higher at a fracture callus compared to the uninjured contralateral bone, vitamin D supplementation leads to decreased time to union and increased callus vascularity, and increases mechanical bone strength compared to controls. While evidence to confirm that vitamin D supplementation improves fracture healing in clinical studies does not exist, the pre-clinical data are compelling and worthy of further investigation. With modern orthopaedic surgical care, rates of complications following tibia and femoral shaft fractures can be as high as 15%. Complications, including delayed union, nonunion, or infection often require secondary surgical procedures and result in profound personal and societal economic costs. While surgeons continue to seek advances in surgical technique, it is becoming increasingly obvious that innovations in orthopaedic techniques or implants are unlikely to eliminate complications. As a result, considerable attention is currently focused on adjunct biologic therapies, such as vitamin D. A recent survey of 397 orthopaedic surgeons showed that only 26% routinely prescribe vitamin D supplementation to adult fracture patients. Of the 93 surgeons who indicated that they routinely prescribe vitamin D supplementation, 29 different dosing regimens were described ranging from low daily doses of 400 IU to loading doses of 600,000 IU. This suggests a high level of clinical uncertainty surrounding the use and optimal dose of vitamin D supplementation in adult fracture patients. If vitamin D supplementation improves fracture healing outcomes, then there is a large opportunity to increase its use; however, before widespread adoption occurs, research is needed to optimize the dosing strategy, establish the dosing safety in the immobilized fracture healing population, and overcome potential medication adherence issues among the often marginalized patients that suffer trauma. The long-term goal of our research program is to conduct a large phase III RCT to determine which dose of vitamin D3 supplementation optimally improves acute fracture healing outcomes in healthy adult patients (18-50 years). The current proposed phase II exploratory trial will perform important preliminary work to test the central hypothesis that vitamin D3 dose and timing of administration is critical for improving fracture healing at 3 months. This trial will also inform the feasibility of the large phase III RCT. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02786498
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Completed
Phase Phase 2
Start date November 21, 2016
Completion date December 1, 2021

See also
  Status Clinical Trial Phase
Withdrawn NCT04470895 - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Unknown status NCT02013986 - Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children Phase 4
Terminated NCT01248182 - Bone to Skin Thickness Study: Obese Versus Normal Population N/A
Recruiting NCT00969839 - NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures Phase 4
Completed NCT00115180 - Racial and Ethnic Disparities in Acute Pain Control N/A
Completed NCT00520442 - Acute Pediatric Fracture Analgesia Study N/A
Not yet recruiting NCT06402292 - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute N/A
Recruiting NCT04947722 - The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care N/A
Recruiting NCT06107699 - The CHARM Study-Coordinating Transitions From Hospital for Older Adults With Fractures N/A
Completed NCT04532580 - Clinical Validation of Boneview for FDA Submission
Completed NCT04237454 - Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years N/A
Recruiting NCT05002335 - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Completed NCT02591043 - Surgical Treatment of Low Energy Pelvic Fractures in the Elderly N/A
Completed NCT02933359 - Osteogenic Profiling of Normal Calvarial Bone
Completed NCT01049191 - Bone Microarchitecture in Women With and Without Fracture N/A
Completed NCT03431857 - Multi Centre Study on TESS V2 Shoulder System
Recruiting NCT04133103 - Early Mobilisation in the Surgical Robot Assisted Spinal Surgery N/A
Completed NCT03993691 - Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System N/A
Active, not recruiting NCT01719887 - Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial N/A