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Clinical Trial Details

Trial ID: L1113
Source ID: NCT02999204
Associated Drug: Vitamin D3
Title: Effect of Vitamin D3 Supplementation on Arterial and Bone Remodeling in Chronic Kidney Disease Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Renal Insufficiency, Chronic|Vascular Stiffness|Bone Diseases, Metabolic
Interventions: DRUG: Vitamin D3
Outcome Measures: Primary: Aortic stiffness evaluated by pulse wave velocity (PWV) (Sphygmocor ® ), Parameter measured in meters per second., 12 months | Secondary: Carotid stiffness evaluated by high resolution echotracking system (Art-lab®)., Parameter measured as the difference in millimeters in carotid artery diameter between systole and diastole., 12 months|Endothelial function evaluated by Endo-PAT2000® system, Parameter measured as the reactive hyperemia index as calculated by the Endo-PAT2000® system software., 12 months|Aortic valve calcification obtained from echocardiography., Parameter measured using a semi-quantitative scoring system based on scale of 1-4 as described by Rosenhek et al, New England Journal of Medicine 2000;343 (9):611. 1-no calcification, 2-mildly calcified (small isolated spots), 3-moderately calcified (multiple larger spots), 4-heavily calcified (extensive thickening and calcification of all cusps)., 12 months|Calcification of the aorta obtained by plain lateral radiography., Parameter measured using a semi-quantitative scoring system based on a scale of 0-3 as described by Kauppila et al, Atherosclerosis 1997;132:245. 0-no calcification, 1-small scattered calcific deposits filling less than 1/3 of the longitudinal wall of the aorta, 2-one third or more, but less than two thirds of the longitudinal wall of the aorta calcified, 3-two thirds or more of the longitudinal wall of the aorta calcified., 12 months|Bone mineral density, Osteodensitometry of the lumbar spine, hip, and distal radius, using dual-energy X-ray absorptiometry and reported in grams per square centimeter., 12 months|Parathyroid hormone levels, Measurement of parathyroid hormone levels using a commercially available intact parathyroid hormone ELISA kit with values reported in ng/L., 12 months
Sponsor/Collaborators: Sponsor: Jewish General Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 57
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2020-10-01
Results First Posted:
Last Update Posted: 2021-02-16
Locations: Jewish General Hospital, Montreal, Quebec, H3T1E2, Canada
URL: https://clinicaltrials.gov/show/NCT02999204