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

NCT01012414 | Terminated Phase 3 Results

• 1 other identifier: 09C.110
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Chronic Kidney Disease; Hypovitaminosis D; Secondary Hyperparathyroidism

Keywords

Vitamin D; Coronary Artery Disease (CAD); Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• Change in High Sensitivity-C Reactive Protein (Serum)

  1 year

Secondary Outcomes (3)

• Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A

  1 year

• Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.

  1 year

• Effect on Carotid Intima-media Thickening (CIMT)

  1 year

Study Arms (2)

oral paricalcitol 2 mcg daily

EXPERIMENTAL

oral paricalcitol 2 mcg daily

Drug: paricalcitol

Placebo

PLACEBO COMPARATOR

one oral placebo drug daily

Drug: placebo

Interventions

paricalcitol DRUG

2 mcg oral paricalcitol daily

Also known as: Zemplar

oral paricalcitol 2 mcg daily

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Abbott: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Renal Insufficiency, Chronic; Vitamin D Deficiency; Hyperparathyroidism, Secondary

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Limitations and Caveats

Early termination secondary to enrollment futility.

Results Point of Contact

• Title: David Whellan MD
• Organization: Thomas Jefferson University

david.whellan@jefferson.edu

215 955 5050

Study Officials

• David J Whellan, MD MHS

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 20, 2014
• Results First Posted: November 11, 2013

Record last verified: 2014-05

Locations

US (1)