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Vitamin D and Coronary Calcification Study (VCOR)

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ClinicalTrials.gov Identifier: NCT00752102
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths. Vascular calcification is a common finding in patients with CKD. Furthermore, patients with CKD develop secondary hyperparathyroidism, partly because of a decrease of calcitriol synthesis on the kidney. Treatment of secondary hyperparathyroidism includes use of activated vitamin D including calcitriol and paricalcitol. Recent evidence in dialysis patients suggest an improved survival in patients using paricalcitol compared to calcitriol.

Studies in uremic rats suggests that there are differential effects of calcitriol and paricalcitol in expression of markers of soft-tissue calcification independent of calcium-phosphorus product. Calcitriol increased calcification of vascular smooth muscle cells cultured in calcification media. There was also significant increase in pulse pressure in animals treated with calcitriol.

The investigators hypothesize that these different forms of vitamin D may have differential effects in vascular calcification progression in CKD patients.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Vitamin D Deficiency Coronary Calcification Disorders of Calcium and Bone Metabolism Drug: Calcitriol (Rocaltrol®) Drug: Paricalcitol Phase 4

Detailed Description:

Coronary artery calcification (CAC) is a risk marker for CVD and mortality. In animal models, calcitriol significantly increased the serum calcium-phosphate product and aortic calcium content, while paricalcitol had no effect. The objective of this randomized, blinded single-center is to determine the differential effect of oral calcitriol and paracalcitol on vascular calcification in patients with chronic kidney disease (CKD).

We performed a total of 89 screening visits and randomized 44 participants. Forty participants completed the final visit. Diagram 1 presents the recruitment schematic.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase IV, Randomized, Single-center Study of the Effects of Calcitriol and Paricalcitol on Vascular Calcification in Chronic Kidney Disease Stages 3 and 4
Study Start Date : September 2008
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Calcitriol

Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/ml of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants.

Subjects taking calcitriol started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels.

Drug: Calcitriol (Rocaltrol®)
Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
Other Names:
  • Calcijex®
  • Rocaltrol®
Active Comparator: Paricalcitol

Paricalcitol, USP, the active ingredient in Zemplar® Capsules, is a synthetically manufactured analog of calcitriol, the metabolically active form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease. Zemplar is available as soft gelatin capsules for oral administration containing 1 mcg, 2 mcg or 4 mcg of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene.

Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels.

Drug: Paricalcitol
Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
Other Name: Zemplar®


Outcome Measures

Primary Outcome Measures :
  1. Coronary Artery (CAC) Score Progression [ Time Frame: 48 weeks ]

    coronary artery (CAC) score difference between baseline and followup CT scans. It was measured in Agatston units. These are units of amount of calcification in the blood vessels so it's a continuous variable. The amount of calcium was quantified with the Agatston scoring method. Calcium scores were adjusted with a standard calcium phantom that was scanned along with the participant. The phantom contained known calcium density bars and provided a way to calibrate the x-ray attenuation level.

    Participants scoring CAC >400 are considered to be at risk for having at least one coronary lesion.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CKD stages 3 or 4 (estimated glomerular filtration rate (eGFR) between 15 and 59)
  • Diagnosis of secondary hyperparathyroidism, which is defined as:

    • Elevated intact PTH (iPTH) as per KDIGO guidelines:

      • CKD stage 3 (eGFR 30-59) or CKD stage 4 (eGFR 15-29) with iPTH > Upper Limit of Normal for lab (6.8 pmol/L)
  • Presence of Coronary Artery Calcium (CAC > 0)
  • Subject will be able to complete the study, to the best of his/her knowledge

Exclusion Criteria:

  • iPTH >1500 pg/ml
  • Current or previous use of bisphosphonates
  • History of parathyroidectomy or anticipated parathyroidectomy
  • History of cinacalcet use
  • History of a solid organ transplant or scheduled date for transplant surgery
  • History of coronary revascularization (coronary artery bypass surgery or percutaneous intervention)
  • History of coronary artifact (e.g. pacemaker, intracardiac defibrillator, artificial valve or biventricular leads)
  • Active atrial fibrillation
  • Weight greater than 300 pounds (due to limitations of equipment)
  • HIV positive
  • Current pregnancy (although pregnancy is very rare in the CKD population)
  • Life expectancy less than two years as judged by primary physician
  • Institutionalized patients (nursing home or prisoners)
  • Language barrier or mental incapacity to consent
  • Inability to swallow tablets or current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752102


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Joslin Diabetes Center
Abbott
Investigators
Principal Investigator: Sylvia E Rosas, MD, MSCE Joslin Diabetes Center
More Information

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00752102     History of Changes
Other Study ID Numbers: Abbott #20128
First Posted: September 15, 2008    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Joslin Diabetes Center:
Secondary Hyperparathryoidism
Chronic Kidney Disease
Vitamin D
Coronary Calcification
Bone metabolism

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Calcinosis
Urologic Diseases
Renal Insufficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcitriol
Butylated Hydroxytoluene
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Antioxidants
Protective Agents