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Supplementation With Cholecalciferol in Dialysis Patients

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Cholecalciferol, Kidney diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Cholecalciferol

Arm Description

100 drops/week for 12 weeks

Drug: Cholecalciferol - 100,000 IU/week

Outcomes

Primary Outcome Measures

Change From Baseline in Interleukin-6 at 12 Weeks.

Secondary Outcome Measures

Change From Baseline in C-reactive Protein at 12 Weeks

Full Information

First Posted
October 8, 2013
Last Updated
December 16, 2014
Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01974245
Brief Title
Supplementation With Cholecalciferol in Dialysis Patients
Official Title
Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Cholecalciferol, Kidney diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 drops/week for 12 weeks
Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Description
Drug: Cholecalciferol - 100,000 IU/week
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamina D3
Intervention Description
100,000 IU/week for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 drops/ week for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Interleukin-6 at 12 Weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in C-reactive Protein at 12 Weeks
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian Cuppari, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marion S Meireles, Master
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria A Kamimura, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04039-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27161894
Citation
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.
Results Reference
derived

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Supplementation With Cholecalciferol in Dialysis Patients

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