Supplementation With Cholecalciferol in Dialysis Patients

• ClinicalTrials.gov Identifier: NCT01974245
• Recruitment Status: Completed
• First Posted: November 1, 2013
• Results First Posted: December 12, 2014
• Last Update Posted: January 6, 2015
• Sponsor: Federal University of São Paulo
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Information provided by (Responsible Party): Lilian Cuppari, Federal University of São Paulo

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease	Drug: Cholecalciferol; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis
• Study Start Date: July 2012
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Interleukin-6 at 12 Weeks. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Change From Baseline in C-reactive Protein at 12 Weeks [ Time Frame: 12 weeks ]

Other Outcome Measures:

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 [ Time Frame: 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Lilian Cuppari, Afilliate Professor, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT01974245
• Other Study ID Numbers: CNPq473838/2011-7
• First Posted: November 1, 2013
• Results First Posted: December 12, 2014
• Last Update Posted: January 6, 2015
• Last Verified: December 2014

Keywords provided by Lilian Cuppari, Federal University of São Paulo:

Cholecalciferol; Kidney diseases

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency; Cholecalciferol; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Bone Density Conservation Agents