Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease (VINCA-CKD)

This study has been terminated.
(Futility in enrollment as of May 31, 2011)
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01012414
First received: November 11, 2009
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Chronic Kidney Disease
Hypovitaminosis D
Secondary Hyperparathyroidism
Drug: paricalcitol
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Supplementation on Markers of Inflammation in High-Risk Cardiovascular Patients With Low Levels of Serum 25-Hydroxyvitamin D

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Change in High Sensitivity-C Reactive Protein (Serum) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Effect on Carotid Intima-media Thickening (CIMT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral paricalcitol 2 mcg daily
oral paricalcitol 2 mcg daily
Drug: paricalcitol
2 mcg oral paricalcitol daily
Other Name: Zemplar
Placebo Comparator: Placebo
one oral placebo drug daily
Drug: placebo
placebo

Detailed Description:

Vitamin D deficiency is common and has been associated with an increased risk of heart disease. In patients with the combination of kidney disease and heart disease, inflammation is thought to contribute to a high rate of cardiac events. Less is known about the effects of vitamin D supplementation on certain tests associated with inflammation in the body.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012414

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Abbott
Investigators
Principal Investigator: David J Whellan, MD MHS Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01012414     History of Changes
Other Study ID Numbers: 09C.110
Study First Received: November 11, 2009
Results First Received: May 30, 2013
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Vitamin D
Coronary Artery Disease (CAD)
Chronic Kidney Disease (CKD)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperparathyroidism
Hyperparathyroidism, Secondary
Inflammation
Kidney Diseases
Rickets
Avitaminosis
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Parathyroid Diseases
Endocrine System Diseases
Pathologic Processes
Urologic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency

ClinicalTrials.gov processed this record on April 15, 2014