Supplementation With Cholecalciferol in Dialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974245
• Other study ID #: CNPq473838/2011-7
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2013
• Last updated: December 16, 2014
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Expression in Monocytes of Vitamin D Receptor, a 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks		12 weeks	No
Primary	Change From Baseline in Interleukin-6 at 12 Weeks.		12 weeks	No
Secondary	Change From Baseline in C-reactive Protein at 12 Weeks		12 weeks	No