Supplementation With Cholecalciferol in Dialysis Patients
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially
in those undergoing dialysis. The loss of protein to the dialysis solution seems to
contribute significantly to the reduced serum levels of vitamin D in these patients. As a
result of the disease and the dialysis procedure, there is high prevalence of chronic
inflammation and high risk of infections. There is evidence in other populations, that
vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an
antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this
study aims to investigate the effects of cholecalciferol supplementation on immunological
markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is
a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D
deficiency [25 (OH) D <20 ng / mL] will be allocated to the intervention group
(cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week
cholecalciferol a period of 12 weeks. Before and after the intervention will be determined
25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive
protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor
and α 1-hydroxylase enzyme expression.
Phase:
Phase 2
Details
Lead Sponsor:
Federal University of São Paulo
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico