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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01911169 |
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Date of registration:
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22/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vitamin D to Improve Endothelial Function in SLE
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Scientific title:
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Vitamin D Repletion to Improve Endothelial Function in Lupus Patients |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01911169 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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James Oates, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of South Carolina |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atherosclerosis
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Cholecalciferol
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change in Interferon Signature
[Time Frame: from zero to sixteen weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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