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Supplementation With Cholecalciferol in Dialysis Patients

This study has been completed.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Lilian Cuppari, Federal University of São Paulo Identifier:
First received: October 8, 2013
Last updated: December 16, 2014
Last verified: December 2014
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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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:
  • Change From Baseline in Interleukin-6 at 12 Weeks. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change From Baseline in C-reactive Protein at 12 Weeks [ Time Frame: 12 weeks ]

Other Outcome Measures:
  • 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 ]

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
Drug: 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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01974245

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
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lilian Cuppari, Afilliate Professor, Federal University of São Paulo Identifier: NCT01974245     History of Changes
Other Study ID Numbers: CNPq473838/2011-7
Study First Received: October 8, 2013
Results First Received: December 5, 2014
Last Updated: December 16, 2014

Keywords provided by Federal University of São Paulo:
Kidney diseases

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 24, 2017