Supplementation With Cholecalciferol in Dialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Marion Schneider Meireles, MsC, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01974245
First received: October 8, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Drug: Cholecalciferol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Reduction of immunological markers with cholecalciferol supplementation at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness of normalization of 25(OH)D level after cholecalciferol supplementation at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Expression of 25(OH)D receptor and α 1-hydroxylase enzyme with cholecalciferol supplementation at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The placebo group did not present effects on immunological markers, 25(OH)D levels and 25(OH)D receptor and 1-alfa hydroxylase enzyme after cholecalciferol supplementation at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
100 drops/week for 12 weeks
Active Comparator: Cholecalciferol
Drug: Cholecalciferol - 100,000 IU/week
Drug: Cholecalciferol
100,000 IU/week for 12 weeks
Other Name: Vitamina D3

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974245

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04039-000
Sponsors and Collaborators
Federal University of São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Marion Schneider Meireles, MsC, Afilliate Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01974245     History of Changes
Other Study ID Numbers: CNPq473838/2011-7
Study First Received: October 8, 2013
Last Updated: October 7, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Cholecalciferol
Kidney diseases

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Cholecalciferol
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014