Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum Bicarbonate Levels
研究概览
简要总结
This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.
详细描述
This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated GFR < 45 ml/min/1.73m2 and >15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation
排除标准
- •Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
- •Bicarbonate level <20 or >25 mEq/L
- •Decompensated heart failure
- •Systolic blood pressure >160 mm/Hg
- •Moderate or greater lower extremity edema
- •Initiation of ESRD treatment planned within 6 months
- •Kidney transplantation
- •Treatment with immunosuppressives within the last 3 months
研究组 & 干预措施
Sodium Bicarbonate
Sequential design. Participants will be getting different doses of sodium bicarbonate during the study.
干预措施: Sodium bicarbonate (Drug)
Placebos
Sequential design. Participants will be getting either placebo of different doses during the study.
干预措施: Placebos (Drug)
结局指标
主要结局
Serum Bicarbonate Levels
时间窗: 8 weeks
次要结局
- Muscle Strength as Measured by sit-to Stand Test(8 weeks)
- Systolic Blood Pressure(8 weeks)
研究者
Michal L. Melamed
Assistant Professor
Albert Einstein College of Medicine