Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02786498
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2016-05-11
Brief Title:
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Blinded Exploratory Randomized Controlled Trial RCT to Determine Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vita-Shock
Brief Summary:
The objective is to determine the effect of vitamin D3 supplementation on fracture healing at 3 months
Detailed 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 600000 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
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 600000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None