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Sponsors and Collaborators: |
Hamilton Health Sciences Merck Frosst Canada Ltd. |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00424619 |
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.
Condition | Intervention | Phase |
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Acute Hip Fracture Patients |
Drug: Vitamin D2 Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment |
Official Title: | A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients |
Estimated Enrollment: | 66 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
50 000 IU Vitamin D2
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Drug: Vitamin D2
50 000 IU vitamin D2, one time bolus dose
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2: Active Comparator
100 000 IU Vitamin D2
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Drug: Vitamin D2
100 000 IU vitamin D2, one time bolus dose
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3: Placebo Comparator
Placebo
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Drug: Placebo
Placebo, 1 time bolus dose
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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- 75/80 nmol/L. 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 (i.e. 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 nmol/l and less than 150-200 nmol/L). 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 IU/day 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 (i.e. 50,000 IU or greater/week) offers an advantage over smaller, routinely prescribed doses (i.e. 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. 50,000 D2 oral bolus followed by 800 IU D3 daily B. 100,000 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 nmol/L) 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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janet M Pritchard, BSc KIN | 905-521-2100 ext 74161 | pritchar@hhsc.ca |
Contact: Madeline Nixon, BSc KIN | 905-521-2100 ext 74004 | nixonm@hhsc.ca |
Canada, Ontario | |
Henderson General Hospital, 711 Concession Street | Recruiting |
Hamilton, Ontario, Canada, L8V 1C3 | |
Principal Investigator: Alexandra Papaioannou, M.D., M.Sc. |
Principal Investigator: | Alexandra Papaioannou, M.D., M.Sc. | McMaster University |
Responsible Party: | McMaster University ( Dr. Alexandra Papaioannou ) |
Study ID Numbers: | 06-449, P1975 |
Study First Received: | January 17, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00424619 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Vitamin D Hip fracture Optimal level Deficiency Functional muscle strength |
Ergocalciferol Fractures, Bone Wounds and Injuries Ergocalciferols Disorders of Environmental Origin Bone Density Conservation Agents Trace Elements Hip Fractures |
Femoral Fractures Vitamin D Vitamin D2 Vitamins Leg Injuries Micronutrients Calciferol |
Growth Substances Fractures, Bone Physiological Effects of Drugs Wounds and Injuries Ergocalciferols Disorders of Environmental Origin Bone Density Conservation Agents Hip Injuries |
Pharmacologic Actions Hip Fractures Femoral Fractures Vitamin D Vitamins Leg Injuries Micronutrients |