Supplementation With Cholecalciferol in Dialysis Patients

Federal University of São Paulo

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01974245

CNPq473838/2011-7

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

100 drops/week for 12 weeks

Treatment:

Drug: Placebo

Cholecalciferol

Active Comparator group

Description:

Drug: Cholecalciferol - 100,000 IU/week

Treatment:

Drug: Cholecalciferol