Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 25-hydroxyvitamin D Levels at 12 Weeks
研究概览
简要总结
Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D < 30 ng/mL
排除标准
- •Patients with a history of active infection within 3 months,
- •Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
- •Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
- •Patients with a history of hospital admission within 3 months,
- •Patients with a history of bleeding within 3 months,
- •Patients with thrombocytopenia,
- •Patients with current use of warfarin,
- •Patients with an albumin level < 3.0 g/dL,
- •Patients with malignancy and/or liver cirrhosis
研究组 & 干预措施
Omega-3 fatty acid
干预措施: cholecalciferol (Other)
Omega-3 fatty acid
干预措施: Omega-3 fatty acid ethylester 90 (Drug)
Olive oil
干预措施: Olive oil (Other)
Olive oil
干预措施: cholecalciferol (Other)
结局指标
主要结局
25-hydroxyvitamin D Levels at 12 Weeks
时间窗: 12 weeks
次要结局
- Change of FGF-23 Levels(12 weeks)
- Changes of Phosphorous Levels(4 weeks, 8 weeks and 12 weeks)
- Changes of Erythropoietin Doses(4 weeks, 8 weeks and 12 weeks)
- Changes of Phosphate Binder Doses(4 weeks, 8 weeks and 12 weeks)
- Hemoglobin Levels at 12 Weeks(12 weeks)
- Changes of Calcium Levels(4 weeks, 8 weeks and 12 weeks)
- Change of Intact Parathyroid Hormone(12 weeks)
- Change of Fetuin-A Levels(12 weeks)
研究者
WON SUK AN
Principal Investigator
Dong-A University