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

NCT03306758 | Unknown

• 1 other identifier: B2017-136R
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asymptomatic Hyperuricemia; Gout

Outcome Measures

Primary Outcomes (1)

• Serum uric acid

  Change from baseline serum levels of uric acid at 1 month

  1 month after randomization

Secondary Outcomes (1)

• Fraction excretion of uric acid

  1 month after randomization

Study Arms (2)

Experimental: sodium bicarbonate

EXPERIMENTAL

Drug: Sodium Bicarbonate

No Intervention

NO INTERVENTION

Interventions

Sodium Bicarbonate DRUG

Sodium Bicarbonate was given 1g tid for one month

Experimental: sodium bicarbonate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign informed consent form;
• Serum uric acid ≥420mmol/L;
• Within the age range of 18-65 years old;
• Within the BMI range of 18-30kg/m2;
• Both men and women are eligible

You may not qualify if:

• 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.
• Taking part in another trail
• Gout flares happening over the last one month;
• Administration of medications over the last one month, including: allopurinol, Febuxostat,benzbromarone, and/or sodium bicarbonate；
• urine pH\>7.0;
• Hepatic function：ALT and/or AST and/or TB\>1.5 upper limit of normal (ULN);
• Renal function：eGFR\<60 ml/min for MDRD and/or urine protein\>0.5g/24h；
• Hypertension：\>140/90mmHg;
• Type 2 diabetes or taking drugs for lowering glucose (not including prediabetes);
• Urinary stone,urinary infection;
• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Gout

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 11, 2017
• Study Start: November 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: September 30, 2018
• Last Updated: October 11, 2017

Record last verified: 2017-09