The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Primary Purpose
Asymptomatic Hyperuricemia, Gout
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sodium Bicarbonate
Sponsored by
About this trial
This is an interventional treatment trial for Asymptomatic Hyperuricemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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;
- Disease which influence serum uric acid, such as cancer, lymphoma, and etc.
- Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc;
- Blood donation or excessive loss of blood over the last 3 month.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: sodium bicarbonate
No Intervention
Arm Description
Outcomes
Primary Outcome Measures
Serum uric acid
Change from baseline serum levels of uric acid at 1 month
Secondary Outcome Measures
Fraction excretion of uric acid
Change from baseline fraction excretion of uric acid at 1 month
Full Information
NCT ID
NCT03306758
First Posted
September 27, 2017
Last Updated
October 5, 2017
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03306758
Brief Title
The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Official Title
The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Hyperuricemia, Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: sodium bicarbonate
Arm Type
Experimental
Arm Title
No Intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Sodium Bicarbonate was given 1g tid for one month
Primary Outcome Measure Information:
Title
Serum uric acid
Description
Change from baseline serum levels of uric acid at 1 month
Time Frame
1 month after randomization
Secondary Outcome Measure Information:
Title
Fraction excretion of uric acid
Description
Change from baseline fraction excretion of uric acid at 1 month
Time Frame
1 month after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
Disease which influence serum uric acid, such as cancer, lymphoma, and etc.
Severe disorders involving heart, liver, kidneys, brain, lungs,digestive tract, rheumatoid disease, blood, endocrine, infection, and etc;
Blood donation or excessive loss of blood over the last 3 month.
12. IPD Sharing Statement
Learn more about this trial
The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
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