Treatment of Hypovitaminosis D in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00423358
First received: January 17, 2007
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: May 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Rheumatoid Arthritis
Hypovitaminosis D
Interventions: Dietary Supplement: Vitamin D
Dietary Supplement: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vitamin D

ergocalciferol 50,000 IU Twice monthly

Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year

Placebo

matching placebo tablet

placebo: matching placebo


Participant Flow:   Overall Study
    Vitamin D     Placebo  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     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
Vitamin D

ergocalciferol 50,000 IU Twice monthly

Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year

Placebo

matching placebo tablet

placebo: matching placebo

Total Total of all reporting groups

Baseline Measures
    Vitamin D     Placebo     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     9     15  
>=65 years     5     2     7  
Age  
[units: years]
Mean (Standard Deviation)
  63  (12)     53  (11)     58  (12)  
Gender  
[units: participants]
     
Female     4     6     10  
Male     7     5     12  
Region of Enrollment  
[units: participants]
     
United States     11     11     22  



  Outcome Measures
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1.  Primary:   Parathyroid Hormone Level   [ Time Frame: 1 Year ]

2.  Secondary:   Bone Mineral Density   [ Time Frame: 1 Year ]

3.  Secondary:   Short Form 36 Survey   [ Time Frame: 1 Year ]


  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: Karen E Hansen, MD, MS
Organization: University of Wisconsin
phone: 608-263-3457
e-mail: keh@medicine.wisc.edu


Publications of Results:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00423358     History of Changes
Other Study ID Numbers: 2004-0011, K23AR050995
Study First Received: January 17, 2007
Results First Received: May 29, 2015
Last Updated: July 27, 2015
Health Authority: United States: Institutional Review Board