跳至主要内容
临床试验/NCT01974245
NCT01974245已完成2 期

Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Change From Baseline in Interleukin-6 at 12 Weeks.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 25 (OH) < 20 ng/ml
  • Peritoneal dialysis or hemodialysis > 3 months

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

100 drops/week for 12 weeks

干预措施: Placebo (Drug)

Cholecalciferol

Active Comparator

Drug: Cholecalciferol - 100,000 IU/week

干预措施: Cholecalciferol (Drug)

结局指标

主要结局

Change From Baseline in Interleukin-6 at 12 Weeks.

时间窗: 12 weeks

次要结局

  • Change From Baseline in C-reactive Protein at 12 Weeks(12 weeks)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilian Cuppari

Afilliate Professor

Federal University of São Paulo

研究点 (1)

Loading locations...

相似试验