Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Intracellular magnesium
研究概览
简要总结
Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.
详细描述
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in chronic kidney disease by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. A trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with CKD is currently being planned, but prior to initiating such a trial it is necessary to determine the dose of oral magnesium needed to increase intracellular magnesium and serum magnesium.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated Glomerular filtration rate (eGFR) < 60 mL/min.
- •Serum magnesium < 0.82 mmol/L.
- •Written informed consent.
排除标准
- •Hemodialysis.
- •Peritoneal dialysis.
- •Kidney transplant recipient.
- •Parathyroid hormone > 600 pg/L.
- •Pregnancy.
- •Comorbidity that makes study participation and completion impossible.
研究组 & 干预措施
Placebo
Oral placebo twice daily for 8 weeks. 12 subjects.
干预措施: Placebo (Drug)
Mablet 360 mg once daily
Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
干预措施: Mablet 360 mg (Drug)
Mablet 360 mg once daily
Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
干预措施: Placebo (Drug)
Mablet 360 mg twice daily
Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.
干预措施: Mablet 360 mg (Drug)
结局指标
主要结局
Intracellular magnesium
时间窗: 8 weeks
Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).
次要结局
- Ionized serum magnesium(8 weeks)
- Total serum magnesium(8 weeks)
研究者
Iain Bressendorff
Medical Doctor
Zealand University Hospital