The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
NCT ID: NCT03306758
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
104 participants
INTERVENTIONAL
2017-11-01
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: sodium bicarbonate
Sodium Bicarbonate
Sodium Bicarbonate was given 1g tid for one month
No Intervention
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sodium Bicarbonate
Sodium Bicarbonate was given 1g tid for one month
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Zhongshan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jiang lindi
Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B2017-136R
Identifier Type: -
Identifier Source: org_study_id