Asymptomatic Hyperuricemia, Gout
Conditions
Brief summary
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.
Interventions
DRUGSodium Bicarbonate
Sodium Bicarbonate was given 1g tid for one month
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Sign informed consent form; 2. Serum uric acid ≥420mmol/L; 3. Within the age range of 18-65 years old; 4. Within the BMI range of 18-30kg/m2; 5. Both men and women are eligible
Exclusion criteria
1. 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. 2. Taking part in another trail 3. Gout flares happening over the last one month; 4. Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate； 5. urine pH\>7.0; 6. Hepatic function：ALT and/or AST and/or TB\>1.5 upper limit of normal (ULN); 7. Renal function：eGFR\<60 ml/min for MDRD and/or urine protein\>0.5g/24h； 8. Hypertension：\>140/90mmHg; 9. Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes); 10. Urinary stone,urinary infection; 11. 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; 12. Disease which influence serum uric acid, such as cancer, lymphoma, and etc. 13. Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc; 14. Blood donation or excessive loss of blood over the last 3 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum uric acid | 1 month after randomization | Change from baseline serum levels of uric acid at 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction excretion of uric acid | 1 month after randomization | Change from baseline fraction excretion of uric acid at 1 month |
Outcome results
None listed