Supplementation With Cholecalciferol in Dialysis Patients

NCT01974245 | Completed Phase 2 Results DMC

• 1 other identifier: CNPq473838/2011-7
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Cholecalciferol; Kidney diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Interleukin-6 at 12 Weeks.

  12 weeks

Secondary Outcomes (1)

• Change From Baseline in C-reactive Protein at 12 Weeks

  12 weeks

Other Outcomes (1)

• Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100 drops/week for 12 weeks

Drug: Placebo

Cholecalciferol

ACTIVE COMPARATOR

Drug: Cholecalciferol - 100,000 IU/week

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

100,000 IU/week for 12 weeks

Also known as: Vitamina D3

Cholecalciferol

Placebo DRUG

100 drops/ week for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (OH) \< 20 ng/ml
• Peritoneal dialysis or hemodialysis \> 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Federal University of São Paulo

São Paulo, 04039-000, Brazil

Location

Related Publications (1)

• Meireles MS, Kamimura MA, Dalboni MA, Giffoni de Carvalho JT, Aoike DT, Cuppari L. Effect of cholecalciferol on vitamin D-regulatory proteins in monocytes and on inflammatory markers in dialysis patients: A randomized controlled trial. Clin Nutr. 2016 Dec;35(6):1251-1258. doi: 10.1016/j.clnu.2016.04.014. Epub 2016 Apr 26.

  PMID: 27161894 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Lilian Cuppari
• Organization: Federal University of São Paulo

lcuppari@uol.com.br

+551159048499

Study Officials

• Lilian Cuppari, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Marion S Meireles, Master

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Maria A Kamimura, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Afilliate Professor

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: November 1, 2013
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 14, 2025
• Results First Posted: December 12, 2014

Record last verified: 2025-02

Locations

BR (1)