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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03306758
• Other study ID #: B2017-136R
• Status: Not yet recruiting
• Phase: N/A
• First received: September 27, 2017
• Last updated: October 5, 2017
• Start date: November 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2017
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: September 30, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asymptomatic Hyperuricemia
• Gout
• Hyperuricemia

Intervention

Drug:
• Sodium Bicarbonate
Sodium Bicarbonate was given 1g tid for one month

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum uric acid	Change from baseline serum levels of uric acid at 1 month	1 month after randomization
Secondary	Fraction excretion of uric acid	Change from baseline fraction excretion of uric acid at 1 month	1 month after randomization