NCT03306758Unknown不适用
The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Shanghai Zhongshan Hospital0 个研究点目标入组 104 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 主要终点
- Serum uric acid
研究概览
简要总结
This study evaluate the serum uric acid lowering effect of sodium bicarbonate as well as its safety in patients with asymptomatic hyperuricemia or gout. Half of the participants will receive sodium bicarbonate only, while the other half receive none.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent form;
- •Serum uric acid ≥420mmol/L;
- •Within the age range of 18-65 years old;
- •Within the BMI range of 18-30kg/m2;
- •Both men and women are eligible
排除标准
- •General situations
- •Pregnancy or lactation；
- •Participants who can't take contraception during the study or within one month after the completion of the intervention;
- •Situations which will harm the participants;
- •Participants with bad compliance.
- •Taking part in another trail
- •Gout flares happening over the last one month;
- •Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate；
- •urine pH>7.0;
- •Hepatic function：ALT and/or AST and/or TB>1.5 upper limit of normal (ULN);
- •Renal function：eGFR<60 ml/min for MDRD and/or urine protein>0.5g/24h；
- •Hypertension：>140/90mmHg;
- •Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes);
- •Urinary stone,urinary infection;
- •Taking drugs ove the last one month and during the trial, including：thiazide diuretic, Loop diuretics, pyrazinamide,ethambutol, tacrolimus, niacin, aspirin, estrogen, losartan, amlodipine, reserpine, vitamin C，fenofibrate，atorvastatin， sulfonylureas，biguanides，NSAIDs;
- •Disease which influence serum uric acid, such as cancer, lymphoma, and etc.
- •Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc;
- •Blood donation or excessive loss of blood over the last 3 month.
研究组 & 干预措施
Experimental: sodium bicarbonate
Experimental
干预措施: Sodium Bicarbonate (Drug)
结局指标
主要结局
Serum uric acid
时间窗: 1 month after randomization
Change from baseline serum levels of uric acid at 1 month
次要结局
- Fraction excretion of uric acid(1 month after randomization)
研究者
Jiang lindi
Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital
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