Federal University of São Paulo
São Paulo, 04039-000, Brazil
NCT Number: NCT01974245
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 2
São Paulo, 04039-000, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100,000 IU/week for 12 weeks
Other names: Vitamina D3
100 drops/ week for 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Federal University of São Paulo
Other
Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07531173
Chronic Disease, Chronic Kidney Disease
View Trial DetailsNCT04191824
Cardiovascular Diseases, Chronic Disease
Birmingham, Alabama, United States
View Trial DetailsNCT00500682
Chronic Disease, Chronic Kidney Disease
Phoenix, Arizona, United States
View Trial DetailsNCT00501046
Chronic Disease, Chronic Kidney Disease
Tuscaloosa, Alabama, United States
View Trial Details