Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424619
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2007-01-17
Brief Title:
A Randomised Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
A Randomised Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Status:
COMPLETED
Status Verified Date:
2012-05
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:
None
Brief Summary:
The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture patients to achieve the optimal therapeutic level
Detailed Description:
Low Vitamin D levels can cause faster bone loss and increase the risk of having a fracture Patients who experience a hip fracture have low levels of Vitamin D It is not clear how much Vitamin D must be taken in order to reach this optimal level
Serum 25-hydroxyvitamin D3 25-OHD concentrations are the recognized functional status indicator for vitamin D Although there is no clear consensus vitamin D insufficiency has been considered in the range of 25- 7580 nmolL Patients with acute hip fracture are at high risk for a recurrent hip fracture or other fragility fractures and falls and are a group who should be targeted for osteoporosis treatment ie Bisphosphonate or other antiresorptive Before fracture patients start on a bisphosphonate however an important consideration is whether 25-OHD levels are at a therapeutic level 75 nmoll and less than 150-200 nmolL Case-control studies indicate that older people who experience a hip fracture have lower serum concentrations of 25-OHD than do those without a fracture In cross-sectional studies the majority of patients with hip fracture are considered to have insufficient vitamin D levels Although the benefits of supplementing patients with at least 800 to 1000 IUday Vitamin D3 may be recognized there is little information available to guide physicians regarding the appropriate management of hip fracture patients who may be severely Vitamin D deficient particularly in acute hip fracture patients Few studies have examined whether high dose vitamin D ie 50000 IU or greaterweek offers an advantage over smaller routinely prescribed doses ie 800 or 1000 IU particularly in hip fracture patients
The purpose of this study is to determine the number of hip fracture patients reaching an optimal level of vitamin D comparing between three different Vitamin D dose strategies
A 50000 D2 oral bolus followed by 800 IU D3 daily B 100000 D2 oral bolus followed by 800 IU D3 daily C 800 IU D3 daily
The Vitamin D strategies will be administered over 3-months in acute hip fracture patients The proportion of patients reaching an optimal level of 25-OHD 75 nmolL will be determined
Secondary measures include the Timed Up and Go test and 2 Minute Walk Test to compare the effects of the Vitamin D supplementation strategies on functional and muscle strength scales
Serum 25-hydroxyvitamin D3 25-OHD concentrations are the recognized functional status indicator for vitamin D Although there is no clear consensus vitamin D insufficiency has been considered in the range of 25- 7580 nmolL Patients with acute hip fracture are at high risk for a recurrent hip fracture or other fragility fractures and falls and are a group who should be targeted for osteoporosis treatment ie Bisphosphonate or other antiresorptive Before fracture patients start on a bisphosphonate however an important consideration is whether 25-OHD levels are at a therapeutic level 75 nmoll and less than 150-200 nmolL Case-control studies indicate that older people who experience a hip fracture have lower serum concentrations of 25-OHD than do those without a fracture In cross-sectional studies the majority of patients with hip fracture are considered to have insufficient vitamin D levels Although the benefits of supplementing patients with at least 800 to 1000 IUday Vitamin D3 may be recognized there is little information available to guide physicians regarding the appropriate management of hip fracture patients who may be severely Vitamin D deficient particularly in acute hip fracture patients Few studies have examined whether high dose vitamin D ie 50000 IU or greaterweek offers an advantage over smaller routinely prescribed doses ie 800 or 1000 IU particularly in hip fracture patients
The purpose of this study is to determine the number of hip fracture patients reaching an optimal level of vitamin D comparing between three different Vitamin D dose strategies
A 50000 D2 oral bolus followed by 800 IU D3 daily B 100000 D2 oral bolus followed by 800 IU D3 daily C 800 IU D3 daily
The Vitamin D strategies will be administered over 3-months in acute hip fracture patients The proportion of patients reaching an optimal level of 25-OHD 75 nmolL will be determined
Secondary measures include the Timed Up and Go test and 2 Minute Walk Test to compare the effects of the Vitamin D supplementation strategies on functional and muscle strength scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P1975 | None | None | None |