| Trial ID: | L1566 |
| Source ID: | NCT00752102
|
| Associated Drug: |
Calcitriol (Rocaltrol®)
|
| Title: |
Vitamin D and Coronary Calcification Study
|
| Acronym: |
VCOR
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00752102/results
|
| Conditions: |
Chronic Kidney Disease|Vitamin D Deficiency|Coronary Calcification|Disorders of Calcium and Bone Metabolism
|
| Interventions: |
DRUG: Calcitriol (Rocaltrol®)|DRUG: Paricalcitol
|
| Outcome Measures: |
Primary: Coronary Artery (CAC) Score Progression, 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., 48 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Joslin Diabetes Center | Collaborators: Abbott
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2008-09
|
| Completion Date: |
2013-10
|
| Results First Posted: |
2017-12-08
|
| Last Update Posted: |
2017-12-08
|
| Locations: |
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19107, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00752102
|
