The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout

Study Overview
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Brief Summary
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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.

Official Title
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The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout

Conditions
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Asymptomatic Hyperuricemia, Gout

Intervention / Treatment
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* Drug: Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: sodium bicarbonate<br> | Drug: Sodium Bicarbonate<br>* Sodium Bicarbonate was given 1g tid for one month<br>|
| No Intervention: No Intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum uric acid | Change from baseline serum levels of uric acid at 1 month | 1 month after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction excretion of uric acid | Change from baseline fraction excretion of uric acid at 1 month | 1 month after randomization |