Status:
COMPLETED
Vitamin D to Improve Endothelial Function in SLE
Lead Sponsor:
Medical University of South Carolina
Conditions:
Atherosclerosis
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Determine the effect of vitamin D repletion on flow mediated dilation (FMD, a measure of endothelial function) in vitamin D deficient systemic lupus erythematosus (SLE) patients. The investigators wil...
Detailed Description
Specific Aim 1. Determine the effect of vitamin D repletion on changes in flow mediated dilation (FMD) in vitamin D deficient SLE patients. The investigators hypothesize that 25(OH)D repletion will im...
Eligibility Criteria
Inclusion
- Diagnosis of SLE per 1997 American College of Rheumatology Criteria(at least 4 criteria present)
- Documented Vitamin D deficiency
- Able to give informed consent
Exclusion
- Using tobacco products
- Pregnant/Planning pregnancy
- Known Hypercalcemia (Serum Ca \>10.4)
- Known Hypercalcuria (Calcium/Creatinine \>0.8)
- Chronic active lupus nephritis or end stage renal disease or kidney stones
- Known Hyperparathyroidism
- Known chronic viral/mycobacterial infections
- Uncontrolled medical disease - Pl judgment
- Current drug or alcohol abuse
- Anticipated poor compliance/known neuropsychiatric disorders
- Hx of cardiovascular events (i.e. Ml, PVD, CVE)
- Subjects taking medications known to affect FMD in lupus subjects such as but not limited to fish oil, statins, will remain on stable doses throughout the study.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01911169
Start Date
June 1 2011
End Date
January 1 2014
Last Update
October 27 2017
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425