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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03306758
Recruitment Status : Unknown
Verified September 2017 by Jiang lindi, Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Jiang lindi, Shanghai Zhongshan Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Experimental: sodium bicarbonate Drug: Sodium Bicarbonate
Sodium Bicarbonate was given 1g tid for one month

No Intervention: No Intervention

Primary Outcome Measures :
  1. Serum uric acid [ Time Frame: 1 month after randomization ]
    Change from baseline serum levels of uric acid at 1 month

Secondary Outcome Measures :
  1. Fraction excretion of uric acid [ Time Frame: 1 month after randomization ]
    Change from baseline fraction excretion of uric acid at 1 month

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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.
  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.
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Responsible Party: Jiang lindi, Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital, Shanghai Zhongshan Hospital Identifier: NCT03306758    
Other Study ID Numbers: B2017-136R
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes