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A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients

This study has been completed.
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier:
NCT00424619
First received: January 17, 2007
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Hip Fracture
Interventions: Drug: Vitamin D2
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
50 000 IU Vitamin D2 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
100 000 IU Vitamin D2 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
Placebo Placebo at beginning of study and 1000IU vitamin D3 for 90 days

Participant Flow for 3 periods

 Period 1:   Baseline
    50 000 IU Vitamin D2     100 000 IU Vitamin D2     Placebo  
STARTED     22     22     21 [1]
COMPLETED     22     22     20  
NOT COMPLETED     0     0     1  
[1] n=21 but one participant was lost as a screen failure

Period 2:   4 Week
    50 000 IU Vitamin D2     100 000 IU Vitamin D2     Placebo  
STARTED     18     17     17  
COMPLETED     18     17     17  
NOT COMPLETED     0     0     0  

Period 3:   3 Month
    50 000 IU Vitamin D2     100 000 IU Vitamin D2     Placebo  
STARTED     12     18     17  
COMPLETED     12     18     17  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
50 000 IU Vitamin D2 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
100 000 IU Vitamin D2 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
Placebo Placebo at beginning of study and 1000IU vitamin D3 for 90 days
Total Total of all reporting groups

Baseline Measures
    50 000 IU Vitamin D2     100 000 IU Vitamin D2     Placebo     Total  
Number of Participants  
[units: participants]
 		  22     22     20     64  
Age  
[units: years]
Mean ± Standard Deviation 		  82.9  ± 8.7     73.9  ± 12.4     78.5  ± 10.3     78.43  ± 11.09  
Gender  
[units: participants]
 		       
Female     15     8     13     36  
Male     7     14     7     28  
Region of Enrollment  
[units: participants]
 		       
Canada     22     22     20     64  



  Outcome Measures
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1.  Primary:   25-hydroxyvitamin D3 (25-OHD)   [ Time Frame: Baseline, 4 weeks and 3 months ]
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Measure Type Primary
Measure Title 25-hydroxyvitamin D3 (25-OHD)
Measure Description Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).
Time Frame Baseline, 4 weeks and 3 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at <13 days were not included. 3-month data (n=47) was missing for 18 participants.

Reporting Groups
  Description
50 000 IU Vitamin D2 50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
100 000 IU Vitamin D2 100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
Placebo Placebo at beginning of study and 1000IU vitamin D3 for 90 days

Measured Values
    50 000 IU Vitamin D2     100 000 IU Vitamin D2     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  20     21     18  
25-hydroxyvitamin D3 (25-OHD)  
[units: nmol/L]
Mean ( 95% Confidence Interval ) 		     
Baseline     53.5  
  ( 42.3 to 64.8 )   		  58.4  
  ( 47.3 to 69.5 )   		  46.7  
  ( 34.8 to 58.6 )  
4-week     84.5  
  ( 73.7 to 95.3 )   		  75.6  
  ( 64.5 to 86.8 )   		  69.3  
  ( 58.4 to 80.2 )  
3-month     84.2  
  ( 73.6 to 94.9 )   		  73.3  
  ( 64.5 to 82.1 )   		  86.7  
  ( 77.6 to 95.9 )  

No statistical analysis provided for 25-hydroxyvitamin D3 (25-OHD)



2.  Primary:   Parathyroid Hormone (PTH)   [ Time Frame: Baseline ]
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3.  Primary:   Calcium   [ Time Frame: Baseline, 4 weeks ]
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4.  Primary:   Phosphate   [ Time Frame: Baseline ]
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5.  Primary:   Alkaline Phosphatase   [ Time Frame: Baseline ]
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6.  Primary:   Hemoglobin   [ Time Frame: Baseline ]
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7.  Primary:   Creatinine   [ Time Frame: Baseline ]
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8.  Secondary:   Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months   [ Time Frame: 3 months ]
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9.  Secondary:   Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months   [ Time Frame: 3 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Alexandra Papaioannou
Organization: McMaster University
phone: 905-521-2100 ext 77715
e-mail: papaioannou@hhsc.ca


No publications provided by McMaster University

Publications automatically indexed to this study:


Responsible Party: Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier: NCT00424619     History of Changes
Other Study ID Numbers: 06-449, P1975
Study First Received: January 17, 2007
Results First Received: July 25, 2011
Last Updated: May 11, 2012
Health Authority: Canada: Ethics Review Committee