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Treatment of Hypovitaminosis D in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00423358
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Rheumatoid Arthritis
Hypovitaminosis D
Interventions: Dietary Supplement: Vitamin D
Dietary Supplement: placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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 ( U.S. NIH Grant/Contract )
First Submitted: January 17, 2007
First Posted: January 18, 2007
Results First Submitted: May 29, 2015
Results First Posted: August 24, 2015
Last Update Posted: August 24, 2015