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

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.

Study Overview

• Status: Unknown
• Conditions: Gout; Asymptomatic Hyperuricemia
• Intervention / Treatment: Drug: Sodium Bicarbonate

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): July 31, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout
• Other Study ID Numbers: B2017-136R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No