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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03306758
• Collaborator: (none)
• Enrollment: 104
• Arms: 2
• Anticipated Duration (Months): 10.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asymptomatic Hyperuricemia; Gout	Drug: Sodium Bicarbonate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
• Anticipated Study Start Date: Nov 1, 2017
• Anticipated Primary Completion Date: Jul 31, 2018
• Anticipated Study Completion Date: Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: sodium bicarbonate	Drug: Sodium Bicarbonate; Sodium Bicarbonate was given 1g tid for one month
No Intervention: No Intervention

Outcome Measures

Primary Outcome Measures

1. Serum uric acid [1 month after randomization]

   Change from baseline serum levels of uric acid at 1 month

Secondary Outcome Measures

1. Fraction excretion of uric acid [1 month after randomization]

   Change from baseline fraction excretion of uric acid at 1 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. Taking part in another trail

2. Gout flares happening over the last one month;

3. Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate；

4. urine pH>7.0;

5. Hepatic function：ALT and/or AST and/or TB>1.5 upper limit of normal (ULN);

6. Renal function：eGFR<60 ml/min for MDRD and/or urine protein>0.5g/24h；

7. Hypertension：>140/90mmHg;

8. Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes);

9. Urinary stone,urinary infection;

10. 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;

11. Disease which influence serum uric acid, such as cancer, lymphoma, and etc.

12. Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc;

13. Blood donation or excessive loss of blood over the last 3 month.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiang lindi, Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital, Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03306758
• Other Study ID Numbers: B2017-136R
• First Posted: Oct 11, 2017
• Last Update Posted: Oct 11, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gout; Hyperuricemia

Study Results

No Results Posted as of Oct 11, 2017