Supplementation With Cholecalciferol in Dialysis Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

100 drops/week for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 drops/ week for 12 weeks

Cholecalciferol

Drug: Cholecalciferol - 100,000 IU/week

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

100,000 IU/week for 12 weeks

Interventions

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Cholecalciferol

100,000 IU/week for 12 weeks

Intervention Type DRUG

Placebo

100 drops/ week for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Vitamina D3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No