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

Fudan University

Status: Unknown

Conditions: Asymptomatic Hyperuricemia; Gout

Treatments: Drug: Sodium Bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT03306758

B2017-136R

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Experimental: sodium bicarbonate

Experimental group

Treatment:

Drug: Sodium Bicarbonate

No Intervention

No Intervention group