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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:
Abbott
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Chronic Kidney Disease
Vitamin D Deficiency
Coronary Calcification
Disorders of Calcium and Bone Metabolism
Interventions Drug: Calcitriol (Rocaltrol®)
Drug: Paricalcitol
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcitriol Paricalcitol
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 22 22
Completed 19 21
Not Completed 3 1
Arm/Group Title Calcitriol Paricalcitol Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
65.8  (7.4) 65.5  (11) 65.6  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
5
  22.7%
13
  59.1%
18
  40.9%
Male
17
  77.3%
9
  40.9%
26
  59.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  63.6%
15
  68.2%
29
  65.9%
White
8
  36.4%
7
  31.8%
15
  34.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22 22 44
1.Primary Outcome
Title Coronary Artery (CAC) Score Progression
Hide Description

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.

Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcitriol Paricalcitol
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Agatston units
74.38  (110.39) 106.32  (126.06)
Time Frame Adverse events were collected during the time between scans (0-48 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcitriol Paricalcitol
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Calcitriol Paricalcitol
Affected / at Risk (%) Affected / at Risk (%)
Total   2/22 (9.09%)      1/22 (4.55%)    
Show Serious Adverse Events Hide Serious Adverse Events
Calcitriol Paricalcitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/22 (40.91%)      8/22 (36.36%)    
Blood and lymphatic system disorders     
Hypoglycemia   0/22 (0.00%)  0 1/22 (4.55%)  1
Cardiac disorders     
hospitalization for congestive heart failure   1/22 (4.55%)  1 0/22 (0.00%)  0
Syncope   1/22 (4.55%)  1 0/22 (0.00%)  0
Hypotensive Episode   1/22 (4.55%)  1 0/22 (0.00%)  0
Chest pain due to cocaine use, Congestive Heart Failure and Shortness of breath   0/22 (0.00%)  0 1/22 (4.55%)  2
Congestive Heart Failure Exacerbation   0/22 (0.00%)  0 1/22 (4.55%)  1
Congestive Heart Failure   0/22 (0.00%)  0 1/22 (4.55%)  1
Uncontrolled blood pressure atime of study - took her to ER   0/22 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders     
Pancreatitis   1/22 (4.55%)  1 0/22 (0.00%)  0
Hospitalization - gastroesophagitis   0/22 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations     
ED visit - 2nd right toe infection   0/22 (0.00%)  0 1/22 (4.55%)  1
Metabolism and nutrition disorders     
Gout flare   0/22 (0.00%)  0 1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders     
Hip dislocation   1/22 (4.55%)  2 0/22 (0.00%)  0
Broken Patella in trip and fall   1/22 (4.55%)  1 0/22 (0.00%)  0
ER visit: fall at home causing back and flank pain   0/22 (0.00%)  0 1/22 (4.55%)  2
ER Visit - Back pain   0/22 (0.00%)  0 1/22 (4.55%)  1
Nervous system disorders     
TIA, confusion   0/22 (0.00%)  0 1/22 (4.55%)  1
Psychiatric disorders     
Psychiatric Hospitalizaton   1/22 (4.55%)  1 0/22 (0.00%)  0
Renal and urinary disorders     
Dialysis Initiation   1/22 (4.55%)  1 0/22 (0.00%)  0
Lower Urinary Tract Symptoms, bladder mass. low grade urothelial carcinoma of bladder, cystoscopy   1/22 (4.55%)  1 0/22 (0.00%)  0
Prostate Cancer   1/22 (4.55%)  1 0/22 (0.00%)  0
Hemodialysis access surgery   0/22 (0.00%)  0 2/22 (9.09%)  2
Hypercalcemia; acute on chronic kideney failure   0/22 (0.00%)  0 1/22 (4.55%)  1
Started hemodialysis   0/22 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders     
Hypercapnic/hypercarbic respiratory failure   0/22 (0.00%)  0 1/22 (4.55%)  2
Hypercarbic respiratory failure - diastolic dysfunction   0/22 (0.00%)  0 1/22 (4.55%)  1
Asthma Exascerbation   0/22 (0.00%)  0 1/22 (4.55%)  1
Hypercarbic respiratory failure, pulmonary edema   0/22 (0.00%)  0 1/22 (4.55%)  1
Shortness of Breath   0/22 (0.00%)  0 1/22 (4.55%)  1
Surgical and medical procedures     
Prostatectomy and Laparoscopic Lymph node Dissection   1/22 (4.55%)  1 0/22 (0.00%)  0
Hip Replacement Surgery   1/22 (4.55%)  1 0/22 (0.00%)  0
ER visit for new CPAP mask   0/22 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Calcitriol Paricalcitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/22 (81.82%)      20/22 (90.91%)    
Blood and lymphatic system disorders     
Mild hyperkalemia   1/22 (4.55%)  1 0/22 (0.00%)  0
Hyperkalemia   2/22 (9.09%)  2 0/22 (0.00%)  0
Edema   0/22 (0.00%)  0 2/22 (9.09%)  2
AVF placement   0/22 (0.00%)  0 1/22 (4.55%)  1
Replacement of nephrostomy tube   0/22 (0.00%)  0 1/22 (4.55%)  1
Increased Edema   0/22 (0.00%)  0 1/22 (4.55%)  1
Azotemia, hyperkalemia   0/22 (0.00%)  0 1/22 (4.55%)  1
Persistent edema   0/22 (0.00%)  0 2/22 (9.09%)  2
Hematoma on knee   0/22 (0.00%)  0 1/22 (4.55%)  1
Cardiac disorders     
2 episodes chest pain while lying down for bed   1/22 (4.55%)  1 0/22 (0.00%)  0
Elevated BP and Edema   1/22 (4.55%)  1 0/22 (0.00%)  0
Hypotension   2/22 (9.09%)  2 0/22 (0.00%)  0
Chest pain, possible muscle pull   0/22 (0.00%)  0 1/22 (4.55%)  1
Congestive heart failure   0/22 (0.00%)  0 1/22 (4.55%)  1
Chest Pain   0/22 (0.00%)  0 1/22 (4.55%)  1
Long QT   0/22 (0.00%)  0 1/22 (4.55%)  1
Endocrine disorders     
Hypercalcemia   0/22 (0.00%)  0 1/22 (4.55%)  1
Eye disorders     
Spontaneous right conjunctival bleed   1/22 (4.55%)  1 0/22 (0.00%)  0
Left eye cataract extraction   1/22 (4.55%)  1 0/22 (0.00%)  0
Right eye cataract extension   1/22 (4.55%)  1 0/22 (0.00%)  0
Cataract Surgery   1/22 (4.55%)  1 0/22 (0.00%)  0
Cataract extraction & lens implantation   0/22 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders     
Diarrhea   1/22 (4.55%)  1 2/22 (9.09%)  2
Vomitting   1/22 (4.55%)  1 0/22 (0.00%)  0
Nausea & vomiting, fatigued, shortness of breath   1/22 (4.55%)  1 1/22 (4.55%)  1
Constipation   1/22 (4.55%)  1 1/22 (4.55%)  1
Nausea   2/22 (9.09%)  3 4/22 (18.18%)  9
Loose stool in AM   1/22 (4.55%)  1 0/22 (0.00%)  0
Metal taste   2/22 (9.09%)  2 3/22 (13.64%)  6
Gastroparesis   1/22 (4.55%)  2 0/22 (0.00%)  0
Increased thirst   0/22 (0.00%)  0 1/22 (4.55%)  1
Nausea, vomiting   0/22 (0.00%)  0 1/22 (4.55%)  1
Problems going to the bathroom   0/22 (0.00%)  0 1/22 (4.55%)  1
General disorders     
Acute Fever s/p biopsy   1/22 (4.55%)  1 0/22 (0.00%)  0
Infections and infestations     
LE cellulitis   0/22 (0.00%)  0 1/22 (4.55%)  1
Injury, poisoning and procedural complications     
Poison ivy   0/22 (0.00%)  0 1/22 (4.55%)  1
Metabolism and nutrition disorders     
Gout flare   1/22 (4.55%)  1 0/22 (0.00%)  0
Severe gout in left foot   0/22 (0.00%)  0 1/22 (4.55%)  1
Anorexia in AM   0/22 (0.00%)  0 1/22 (4.55%)  1
gout flare   0/22 (0.00%)  0 2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders     
Muscle Weakness   1/22 (4.55%)  1 0/22 (0.00%)  0
Hip Pain   1/22 (4.55%)  1 0/22 (0.00%)  0
Hip Dislocation   1/22 (4.55%)  1 0/22 (0.00%)  0
Broken Patella in trip and fall   1/22 (4.55%)  1 0/22 (0.00%)  0
Hand and leg cramps   1/22 (4.55%)  1 0/22 (0.00%)  0
Nocturnal Cramps   1/22 (4.55%)  1 1/22 (4.55%)  1
Left Knee pain   1/22 (4.55%)  1 0/22 (0.00%)  0
Blunt head injury, hip pain following fall from chair   1/22 (4.55%)  1 0/22 (0.00%)  0
Pain in left leg   1/22 (4.55%)  1 0/22 (0.00%)  0
Edema & generalized pain left foot   1/22 (4.55%)  1 0/22 (0.00%)  0
Ankle sprain   1/22 (4.55%)  1 0/22 (0.00%)  0
Weakness, fatigue   1/22 (4.55%)  1 0/22 (0.00%)  0
Swollen Elbow   1/22 (4.55%)  1 0/22 (0.00%)  0
Leg Cramps   0/22 (0.00%)  0 2/22 (9.09%)  2
Diffuse low back pain   0/22 (0.00%)  0 1/22 (4.55%)  1
Back pains   0/22 (0.00%)  0 1/22 (4.55%)  1
knee pain due to fall on bus   0/22 (0.00%)  0 1/22 (4.55%)  1
Worsening flank pain   0/22 (0.00%)  0 1/22 (4.55%)  1
Broken right foot   0/22 (0.00%)  0 1/22 (4.55%)  1
ED Visit - CHF, foot pain   0/22 (0.00%)  0 1/22 (4.55%)  1
Fall at phleobtomy suites   0/22 (0.00%)  0 1/22 (4.55%)  1
Arthritis pain left knee   0/22 (0.00%)  0 1/22 (4.55%)  1
Leg cramping and pains   0/22 (0.00%)  0 1/22 (4.55%)  1
Broken toe   0/22 (0.00%)  0 1/22 (4.55%)  1
Nervous system disorders     
Fatigue   1/22 (4.55%)  1 3/22 (13.64%)  3
Forgetful, "something wrong with head"   1/22 (4.55%)  1 0/22 (0.00%)  0
Headaches, fatigue   1/22 (4.55%)  1 0/22 (0.00%)  0
headache   0/22 (0.00%)  0 3/22 (13.64%)  3
Night Sweats   0/22 (0.00%)  0 1/22 (4.55%)  1
Dizzy, diadiaphoretic, fall in anemia clinic   0/22 (0.00%)  0 1/22 (4.55%)  1
Feels faint in morning   0/22 (0.00%)  0 1/22 (4.55%)  1
Little headache with unbalance   0/22 (0.00%)  0 1/22 (4.55%)  1
Tingling in arms   0/22 (0.00%)  0 1/22 (4.55%)  1
Fleeting dizziness   0/22 (0.00%)  0 1/22 (4.55%)  1
Psychiatric disorders     
ER visit (depression exacerbation)   1/22 (4.55%)  1 0/22 (0.00%)  0
Renal and urinary disorders     
Fistula Placement   1/22 (4.55%)  1 0/22 (0.00%)  0
hyperphosphatemia   1/22 (4.55%)  1 0/22 (0.00%)  0
Uremia Symptoms   1/22 (4.55%)  1 0/22 (0.00%)  0
Kidney pain/ kidney stones   1/22 (4.55%)  1 0/22 (0.00%)  0
Uremic symptoms   0/22 (0.00%)  0 1/22 (4.55%)  1
Hyperphosphatemia   0/22 (0.00%)  0 1/22 (4.55%)  1
Indeterminate left renal mass   0/22 (0.00%)  0 1/22 (4.55%)  1
Nausea & fatigue on passing a stone   0/22 (0.00%)  0 1/22 (4.55%)  1
Fistula placement   0/22 (0.00%)  0 1/22 (4.55%)  1
TDC Cath placement   0/22 (0.00%)  0 1/22 (4.55%)  1
Reproductive system and breast disorders     
Visicoli placement surgery for prostate cancer treatment   1/22 (4.55%)  1 0/22 (0.00%)  0
Hospitalization with UTI   0/22 (0.00%)  0 1/22 (4.55%)  1
Urinary tract infection   0/22 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders     
Viral Upper Respiratory Illness   1/22 (4.55%)  1 0/22 (0.00%)  0
Shortness of Breath, Fatigue   1/22 (4.55%)  1 0/22 (0.00%)  0
Vascular disorders     
Bronchitis   0/22 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sylvia Rosas
Organization: Joslin Diabetes Center
Phone: 617-309-2477
EMail: sylvia.rosas@joslin.harvard.edu
Layout table for additonal information
Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00752102     History of Changes
Other Study ID Numbers: Abbott #20128
First Submitted: September 11, 2008
First Posted: September 15, 2008
Results First Submitted: August 24, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017