Effect of Oral Vitamin D on Oxidative Stress and Inflammation in Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- (25(OH)D)
研究概览
简要总结
Vitamin D deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (CKD) patients, especially those on regular hemodialysis. Being a key regulator in mineral metabolism, there's also emerging evidences linking vitamin D deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients.
It's prospective, randomized trial that's carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin D (25(OH)D) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. Fifty eligible hemodialysis patients were randomly assigned to either Group A (Oral 50.000IU Cholecalciferol, once weekly) or Group B (Oral 200.000IU Cholecalciferol, once monthly), for 3 months. Serum levels of (25(OH)D), serum malondialdehyde (MDA), serum superoxide dismutase (SOD), serum high sensitive (hsCRP), calcium, phosphorus, and intact parathormone (iPTH) levels, were all assessed at baseline and at the end of the study
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18-70 years, on maintenance hemodialysis for a duration of 3 months or more, in a stable clinical condition (no hospitalization in the previous 3 months), with serum vitamin D levels of < 30 ng/ml.
排除标准
- •Patients with hypersensitivity to cholecalciferol, ongoing cholecalciferol therapy, liver failure, digestive malabsorption disease, being participating in an another clinical trial within the past 4 weeks, females that are pregnant or breastfeeding, or patients being judged to be unsuitable to be enrolled by the attending physician.
研究组 & 干预措施
Weekly Cholecalciferol Group
25 hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, taken post-hemodialysis session for 3 months.
干预措施: Cholecalciferol (Drug)
Monthly Cholecalciferol Group
25 hemodialysis patients on Oral 200.000IU Cholecalciferol, once monthly, for 3 months.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
(25(OH)D)
时间窗: 3 months
Change in serum 25-hydroxy vitamin D (25(OH)D) level
次要结局
- intact parathyroid hormone (iPTH)(3 months)
- serum phosphate level (PO4)(3 months)
- serum Malondialdehyde (MDA)(3 months)
- serum high sensitive C-reactive Protein (HsCRP)(3 months)
- serum calcium level (Ca)(3 months)
- serum sodium dismutase (SOD)(3 months)
研究者
Mona AlShahawey Ghazy, PhD
Assistant professor of Clinical Pharmacy
Ain Shams University