Vitamin D Deficiency Clinical Trial
Official title:
Effects of Cholecalciferol on Osteoprotegerin Levels and Other Clinical Outcomes in Chronic Kidney Disease Patients on Peritoneal Dialysis: a Randomized Controlled Trial
Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces proteins levels associated with vascular calcification (osteoprotegerin, osteopontin, osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.
Patients with chronic kidney disease on peritoneal dialysis have very low 25-(OH) vitamin D
levels. Vitamin D deficiency may be involved in generalized atherosclerosis, vascular
calcification and cardiovascular mortality. Among others, Osteoprotegerin (OPG) has been
implicated in the pathogenesis leading up vessel calcification in this patients.
Furthermore, very low levels of 25-(OH) vitamin D in peritoneal dialysis patients are
associated with increased levels of OPG and high values of vascular calcification scores in
x-rays.
It is unknown whether cholecalciferol supplementation in patients on peritoneal dialysis
with low levels of 25-(OH) vitamin D could change the proteins associated with vascular
calcification.
The objective is to conduct a randomized, double-blind, placebo-controlled study focusing on
the impact of Cholecalciferol substitution in 25-OH vitamin D deficient peritoneal dialysis
patients on circulating OPG and other osteogenic biomarkers levels during 16 weeks of
intervention.
Moreover, the impact of cholecalciferol on serum calcium and phosphorus levels, Kidney
Disease Quality of Life Short Form, and ultrasound characteristics of carotid arterial will
be performed during the first four weeks after inclusion, and after 28 weeks
postintervention.
Peritoneal dialysis patients found to have 25-(OH) vitamin D levels <20 ng/ml will be
included and will be randomized to receive either oral cholecalciferol therapy or placebo.
Cholecalciferol will be administered at a daily dose of 4800 IU over a time period of 16
weeks.
All in all, 58 subjects will be included in this study.
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