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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00424619
First Posted: January 19, 2007
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University
Results First Submitted: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   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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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.
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
Total Total of all reporting groups

Baseline Measures
   50 000 IU Vitamin D2   100 000 IU Vitamin D2   Placebo   Total 
Overall Participants Analyzed 
[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 ]

2.  Primary:   Parathyroid Hormone (PTH)   [ Time Frame: Baseline ]

3.  Primary:   Calcium   [ Time Frame: Baseline, 4 weeks ]

4.  Primary:   Phosphate   [ Time Frame: Baseline ]

5.  Primary:   Alkaline Phosphatase   [ Time Frame: Baseline ]

6.  Primary:   Hemoglobin   [ Time Frame: Baseline ]

7.  Primary:   Creatinine   [ Time Frame: Baseline ]

8.  Secondary:   Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months   [ Time Frame: 3 months ]

9.  Secondary:   Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alexandra Papaioannou, McMaster University
ClinicalTrials.gov Identifier: NCT00424619     History of Changes
Other Study ID Numbers: 06-449
P1975
First Submitted: January 17, 2007
First Posted: January 19, 2007
Results First Submitted: July 25, 2011
Results First Posted: June 14, 2012
Last Update Posted: June 14, 2012