Clinical trial NCT01974245: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: Cholecalciferol
Kidney diseases
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-11-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Interleukin-6 at 12 Weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in C-reactive Protein at 12 Weeks
timeFrame: 12 weeks
Other outcomes:
measure: Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks
timeFrame: 12 weeks
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Lilian Cuppari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Marion S Meireles, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Maria A Kamimura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.