Asymptomatic HyperuricemiaNCT03306758
The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
A study testing Sodium Bicarbonate in people with Asymptomatic Hyperuricemia and Gout, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Hyperuricemia, Gout
- What is being tested?
- Sodium Bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
About this study
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
- Being tested
- Sodium Bicarbonate
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BicarbonateDrug
Sodium Bicarbonate was given 1g tid for one month
| Study group | Role | What they receive |
|---|---|---|
| Experimental: sodium bicarbonate | Experimental | Not described Receives: Drug: Sodium Bicarbonate |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid
Change from baseline serum levels of uric acid at 1 month
Measured: 1 month after randomization
Secondary outcomes (1)
Fraction excretion of uric acid
Change from baseline fraction excretion of uric acid at 1 month
Measured: 1 month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion31 Jul 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang lindi, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306758
- Sponsor's protocol ID
- B2017-136R
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout
- ClinicalTrials.gov ID
- NCT03306758
- Acronym / sponsor ID
- B2017-136R
- Conditions
- Asymptomatic Hyperuricemia, Gout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: sodium bicarbonate | Experimental | Drug: Sodium Bicarbonate |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- General situations
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium BicarbonateSodium Bicarbonate was given 1g tid for one month | Drug | Experimental: sodium bicarbonate |
Primary outcome
Serum uric acid
Time frame: 1 month after randomization
Change from baseline serum levels of uric acid at 1 month
1 secondary outcome
Fraction excretion of uric acid
Time frame: 1 month after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate in people with Asymptomatic Hyperuricemia and Gout, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum uric acid (time frame: 1 month after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.