Supplementation With Cholecalciferol in Dialysis Patients

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT01974245
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-11-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2014-12-05
• Results First Submitted QC: 2014-12-05
• Results First Posted: 2014-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100 drops/week for 12 weeks
Cholecalciferol	Cholecalciferol	Drug: Cholecalciferol - 100,000 IU/week

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Interleukin-6 at 12 Weeks.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in C-reactive Protein at 12 Weeks	12 weeks

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil