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Clinical Trial Details

Trial ID: L1480
Source ID: NCT02598635
Associated Drug: Cholecalciferol
Title: Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Vitamin D Deficiency|Vascular Calcification|Renal Insufficiency|End Stage Renal Failure on Dialysis
Interventions: DRUG: Cholecalciferol|DRUG: Placebo
Outcome Measures: Primary: Relative reduction in serum osteoprotegerin (OPG) levels assessed by ELISA (in pg/mL) between study inclusion, and the 16-week intervention period., The concentrations of OPG will be assessed using ELISA (Austin, Texas, USA) at inclusion and after 16 weeks of treatment with cholecalciferol or placebo.Minimum detectable concentrations for OPG are 1.9 pg/mL; intra and inter-assay coefficients of variability are 5% and 11% for OPG., 16 weeks | Secondary: Relative reduction in circulating intact fibroblast growth factor 23 (FGF23) levels (in pg/mL), The concentrations of intact FGF-23 will be assessed using ELISA (Austin, Texas, USA), 16 weeks|Relative reduction in circulating osteopontin (OPN) levels (in pg/mL), The concentrations of OPN will be assessed using ELISA (Austin, Texas, USA), 16 weeks|Relative reduction in circulating osteocalcin (OCN) levels (in pg/mL), The concentrations of OCN will be assessed using ELISA ( Austin, Texas, USA), 16 weeks|Relative reduction in intima-media thickness measurements in the carotid artery. Ultrasound examination will be performed at study inclusion, at 16 weeks after inclusion, and up to 52 weeks post inclusion., Ultrasound examination will be performed with the use of an 8-megahertz annular array ultrasound imaging system by a single trained sonographer. With this technique, 2 parallel echogenic lines separated by an anechoic space can be visualized at levels of the artery wall. The distance between the 2 lines gives a reliable index of the thickness of the intimal-medial complex. Subjects will be examined in the supine position. Ultrasound scans of the right and left last distal centimeter of common carotid arteries and bifurcation and of the first proximal centimeter of internal carotid arteries in 3 different projections (anterior, lateral, and posterior) will be performed. All measurements will be made at the time of scanning on unfrozen images of longitudinal scans by using the machine's electronic caliper., 52 weeks|Number of participants with courses of corrected calcium (>10.5 mg/dL) and phosphorus (>7 mg/dL) levels, During follow-up, all participants will be interviewed. All participants will be interviewed and a blood sample will be taken every 4-6 weeks., 16 weeks
Sponsor/Collaborators: Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-10
Completion Date: 2017-06
Results First Posted:
Last Update Posted: 2017-03-24
Locations: National Medical Science and Nutrition Institute Salvador Zubiran MEXICO, Mexico, Mexico city, 01400, Mexico
URL: https://clinicaltrials.gov/show/NCT02598635