Supplementation With Cholecalciferol in Dialysis Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01974245
Study type	Interventional
Source	Federal University of São Paulo
Contact
Status	Completed
Phase	Phase 2
Start date	July 2012
Completion date	July 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated	`NCT04043026` - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed	`NCT05318014` - Low-protein Formula Supplements in Chronic Kidney Disease	N/A
Active, not recruiting	`NCT06071065` - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients	N/A
Completed	`NCT02878317` - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting	`NCT06039254` - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function	Phase 1
Recruiting	`NCT03160326` - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Withdrawn	`NCT02885545` - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial	Phase 4
Completed	`NCT02896309` - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity	N/A
Completed	`NCT02836574` - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease	Phase 2
Completed	`NCT02875886` - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease	Phase 4
Completed	`NCT02756520` - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Active, not recruiting	`NCT02483039` - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization	N/A
Completed	`NCT02992548` - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease	Phase 4
Completed	`NCT02369549` - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease	Phase 3
Terminated	`NCT02543177` - Optimised Procedure in Patients With NSTEMI and CKD	N/A
Recruiting	`NCT02205944` - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes	N/A
Active, not recruiting	`NCT02231138` - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease	Phase 4