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Vitamin D to Improve Endothelial Function in SLE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01911169
First Posted: July 30, 2013
Last Update Posted: October 27, 2017
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.
Information provided by (Responsible Party):
Jim C. Oates, Medical University of South Carolina
Results First Submitted: April 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Atherosclerosis
Systemic Lupus Erythematosus
Intervention: Drug: Cholecalciferol

  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
Initially, subjects will be recruited from the MUSC/UMA clinics. Once interest is confirmed by the subject, study personnel completed a chart review to determine if basic inclusion/exclusion criteria is met. If pre-screen criteria were met, a screening visit was scheduled where the informed consent process will be completed by PI/Sub-I.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
72 SLE patients were identified with a low 25(OH)D level. Of these, 56 failed further pre-screening based on disease activity, medication use, and known cardiovascular disease. Of the 16 who underwent a screening visit, 7 patients failed to meet criteria for enrollment. Nine patients met inclusion and exclusion criteria and were randomized.

Reporting Groups
  Description
Vitamin D 5000

5,000 IU vitamin D (cholecalciferol) given orally daily

Cholecalciferol: 5,000 International units versus 400 international units as an active comparator

Vitamin D 400

cholecalciferol 400 IU daily by mouth

Cholecalciferol: 5,000 International units versus 400 international units as an active comparator


Participant Flow:   Overall Study
    Vitamin D 5000   Vitamin D 400
STARTED   6   3 
COMPLETED   6   3 
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 5000

5,000 IU vitamin D (cholecalciferol) given orally daily

Cholecalciferol: 5,000 International units versus 400 international units as an active comparator

Vitamin D 400

cholecalciferol 400 IU daily by mouth

Cholecalciferol: 5,000 International units versus 400 international units as an active comparator

Total Total of all reporting groups

Baseline Measures
   Vitamin D 5000   Vitamin D 400   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   3   9 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      3 100.0%      9 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6 100.0%      3 100.0%      9 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  83.3%      3 100.0%      8  88.9% 
White      1  16.7%      0   0.0%      1  11.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D   [ Time Frame: from zero to sixteen weeks ]

2.  Secondary:   Change in Interferon Signature   [ Time Frame: from zero to sixteen weeks ]


  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. James Oates
Organization: Medical University of South Carolina
phone: 843-789-6797
e-mail: oatesjc@musc.edu



Responsible Party: Jim C. Oates, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01911169     History of Changes
Other Study ID Numbers: 00009197
First Submitted: July 22, 2013
First Posted: July 30, 2013
Results First Submitted: April 21, 2016
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017