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Status unknownNCT03306758Updated Oct 11, 2017

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

An interventional study of Sodium Bicarbonate in Asymptomatic Hyperuricemia and Gout, sponsored by Shanghai Zhongshan Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asymptomatic Hyperuricemia
  • Gout

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Experimental: sodium bicarbonate

    Drug: Sodium Bicarbonate

  • No intervention
    No Intervention

Interventions

  • DrugSodium Bicarbonate

    Sodium Bicarbonate was given 1g tid for one month

05

What researchers measure

Primary outcomes

  1. Serum uric acid

    Change from baseline serum levels of uric acid at 1 month

    Time frame: 1 month after randomization

Secondary outcomes

  1. Fraction excretion of uric acid

    Change from baseline fraction excretion of uric acid at 1 month

    Time frame: 1 month after randomization

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03306758
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Jiang lindi (Chief, Professor, Department of Rheumatology, Shanghai Zhongshan Hospital, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Oct 11, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Jul 31, 2018 (estimated)
Completion
Sep 30, 2018 (estimated)
Last update
Oct 11, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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