Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease
Condition: Coronary Artery Disease; Chronic Kidney Disease; Hypovitaminosis D; Secondary Hyperparathyroidism
MeSH terms: Rickets; Kidney Diseases; Renal Insufficiency, Chronic; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Avitaminosis; Vitamin D Deficiency; Hyperparathyroidism; Hyperparathyroidism, Secondary; Inflammation
Intervention: paricalcitol; placebo
Intervention description: 2 mcg oral paricalcitol daily; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Coronary Artery Disease (CAD); Chronic Kidney Disease (CKD)

Summary:

      The purpose of this study is to determine if vitamin D supplementation changes the results of
      certain tests associated with inflammation in the body using an oral, synthetic form of
      vitamin D called paricalcitol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant, non-lactating women greater than 18 years of age

          -  Able to given informed consent and complete scheduled visits

          -  History of established coronary artery disease (CAD)as defined by coronary stenosis in
             one or more vessels greater than or equal to 70% by coronary angiography or CT
             angiogram OR abnormal stress test (at least medium-sized, moderate reversible defect)
             OR a presence of a CAD risk equivalent as defined by the National Cholesterol
             Education Panel (NCEP)III as: Framingham risk score ≥ 20%, diabetes, or peripheral
             arterial disease(4)

          -  High Sensitivity C-reactive Protein (hs-CRP) ≥ 2.0 mg/L

          -  History of stage 3 or 4 chronic Kidney disease (CKD) defined as an glomerular
             filtration rate (eGRF) by the Modification of Diet in Renal Disease (MDRD) formula of
             15-60 mL/min/1.73 m2

          -  Low level of serum 25-hydroxyvitamin D (<30ng/mL)

          -  Evidence of secondary hyperparathyroidism defined as intact parathyroid hormone (iPTH)
             level > 70 pg/mL

          -  Stable dose of statin and/or other lipid lowering therapy (ie: ezetimibe, fibrates,
             bile acid sequestrants nicotinic acid, fish oil) for 12 weeks prior to enrollment
             without known plans for change to current therapy during the study period

        Exclusion Criteria:

          -  History of myocardial infarction, stroke, or cardiac surgery within 6 months of
             enrollment

          -  History of carotid artery surgery

          -  Planned cardiovascular surgery or procedure, with the exception of permanent pacemaker
             placement, in the next 18 months.

          -  Use of vitamin D or calcium supplementation within the past 12 weeks with the
             exception of calcium containing phosphate binders and a daily multivitamin containing
             ≤ 400 IU of vitamin D

          -  Hypercalcemia (as defined by the laboratory upper limit of normal ) or
             hyperphosphatemia (≥ 5.5 mg/dL)

          -  Plan to initiate renal replacement therapy (dialysis) during the study

          -  History of left ventricular systolic dysfunction with an ejection fraction <50% or
             history of New York Heart Association (NYHA)functional Class II-IV congestive heart
             failure

          -  Uncontrolled blood pressure, defined as systolic blood pressure greater than 160 mmHg
             and diastolic blood pressure greater than 100 mm Hg at the screening visit

          -  Uncontrolled diabetes, defined as hemoglobin A1C ≥ 10.0

          -  History of any surgery within the past 3 months or known to be planned during the
             study period

          -  History of malignancy within the past 5 years with the exception of non-melanoma (ie:
             squamous cell or basal cell) skin cancer

          -  History of a known systemic or pulmonary inflammatory condition (including rheumatoid
             arthritis, systemic lupus erythematosus, chronic obstructive pulmonary disease,
             pulmonary fibrosis, sarcoidosis, Wegener's granulomatosis, Goodpasture's disease)

          -  History of renal or other organ transplant and/or immunosuppressed state (ie
             immunosuppressive therapy or condition such as HIV)

          -  History of any other condition, that in the opinion of the investigators renders it
             unsafe for the subject to be enrolled

          -  For woman able to become pregnant, unwillingness to use birth control

          -  Participation in another clinical trial