Trial Outcomes & Findings for Vitamin D and Coronary Calcification Study (NCT NCT00752102)

Last Updated: 2017-12-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

48 weeks

Results posted on

2017-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Calcitriol 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 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 Study STARTED	22	22
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D and Coronary Calcification Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcitriol n=22 Participants 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 n=22 Participants 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 n=44 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 7.4 • n=5 Participants	65.5 years STANDARD_DEVIATION 11 • n=7 Participants	65.6 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome measures
Measure	Calcitriol n=19 Participants 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 n=21 Participants 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.
Coronary Artery (CAC) Score Progression	74.38 Agatston units Standard Deviation 110.39	106.32 Agatston units Standard Deviation 126.06

Adverse Events

Calcitriol

Serious events: 9 serious events

Other events: 18 other events

Deaths: 2 deaths

Paricalcitol

Serious events: 8 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Sylvia Rosas

Joslin Diabetes Center

Phone: 617-309-2477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Calcitriol n=22 participants at risk 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 n=22 participants at risk 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.
Cardiac disorders hospitalization for congestive heart failure	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Renal and urinary disorders Dialysis Initiation	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Cardiac disorders Syncope	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Cardiac disorders Hypotensive Episode	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Surgical and medical procedures Prostatectomy and Laparoscopic Lymph node Dissection	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Renal and urinary disorders Lower Urinary Tract Symptoms, bladder mass. low grade urothelial carcinoma of bladder, cystoscopy	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Musculoskeletal and connective tissue disorders Hip dislocation	4.5% 1/22 • Number of events 2 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Surgical and medical procedures Hip Replacement Surgery	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Psychiatric disorders Psychiatric Hospitalizaton	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Musculoskeletal and connective tissue disorders Broken Patella in trip and fall	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Gastrointestinal disorders Pancreatitis	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Renal and urinary disorders Prostate Cancer	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)
Cardiac disorders Chest pain due to cocaine use, Congestive Heart Failure and Shortness of breath	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 2 • Adverse events were collected during the time between scans (0-48 weeks)
Cardiac disorders Congestive Heart Failure Exacerbation	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Renal and urinary disorders Hemodialysis access surgery	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	9.1% 2/22 • Number of events 2 • Adverse events were collected during the time between scans (0-48 weeks)
Respiratory, thoracic and mediastinal disorders Hypercapnic/hypercarbic respiratory failure	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 2 • Adverse events were collected during the time between scans (0-48 weeks)
Respiratory, thoracic and mediastinal disorders Hypercarbic respiratory failure - diastolic dysfunction	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Surgical and medical procedures ER visit for new CPAP mask	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Respiratory, thoracic and mediastinal disorders Asthma Exascerbation	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Musculoskeletal and connective tissue disorders ER visit: fall at home causing back and flank pain	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 2 • Adverse events were collected during the time between scans (0-48 weeks)
Respiratory, thoracic and mediastinal disorders Hypercarbic respiratory failure, pulmonary edema	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Gastrointestinal disorders Hospitalization - gastroesophagitis	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Nervous system disorders TIA, confusion	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Cardiac disorders Congestive Heart Failure	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Metabolism and nutrition disorders Gout flare	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Renal and urinary disorders Hypercalcemia; acute on chronic kideney failure	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Infections and infestations ED visit - 2nd right toe infection	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Blood and lymphatic system disorders Hypoglycemia	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Renal and urinary disorders Started hemodialysis	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Cardiac disorders Uncontrolled blood pressure atime of study - took her to ER	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)
Musculoskeletal and connective tissue disorders ER Visit - Back pain	0.00% 0/22 • Adverse events were collected during the time between scans (0-48 weeks)	4.5% 1/22 • Number of events 1 • Adverse events were collected during the time between scans (0-48 weeks)