Supplementation With Cholecalciferol in Dialysis Patients

Overview

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.

Full Title of Study: “Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2014

Interventions

  • Drug: Cholecalciferol
    • 100,000 IU/week for 12 weeks
  • Drug: Placebo
    • 100 drops/ week for 12 weeks

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 100 drops/week for 12 weeks
  • Active Comparator: Cholecalciferol
    • Drug: Cholecalciferol – 100,000 IU/week

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Interleukin-6 at 12 Weeks.
    • Time Frame: 12 weeks

Secondary Measures

  • Change From Baseline in C-reactive Protein at 12 Weeks
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • 25 (OH) < 20 ng/ml – Peritoneal dialysis or hemodialysis > 3 months Exclusion Criteria:

  • Use of vitamin D or its analogues, corticosteroids and immunosuppressive – Peritonitis in the previous month at baseline – Liver, neoplastic, infectious or autoimmune diseases and positive HIV – Hypercalcemia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lilian Cuppari, Afilliate Professor – Federal University of São Paulo
  • Overall Official(s)
    • Lilian Cuppari, PhD, Principal Investigator, Federal University of São Paulo
    • Marion S Meireles, Master, Principal Investigator, Federal University of São Paulo
    • Maria A Kamimura, PhD, Principal Investigator, Federal University of São Paulo

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.