Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia: A Study Protocol for a Single-Center, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn whether tart cherry citrate effervescent tablets can lower uric acid levels in people with asymptomatic hyperuricemia (high uric acid levels without gout symptoms).
The main question it aims to answer is:
Does taking tart cherry citrate effervescent tablets lower uric acid levels more effectively than taking a placebo (inactive) tablet, when both groups also receive lifestyle guidance?
Researchers will compare two groups of participants. Both groups will receive lifestyle guidance (advice on diet and exercise). In addition:
- One group will take the tart cherry citrate effervescent tablets.
- The other group will take a placebo effervescent tablet (looks and tastes the same but contains no active ingredient).
The study will last 24 weeks.
Participants will:
- Take the assigned effervescent tablet twice daily for 24 weeks
- Follow lifestyle guidance for diet and exercise
- Attend scheduled clinic visits for checkups and tests
- Provide blood and urine samples for testing
详细描述
Background and Rationale Hyperuricemia, a common metabolic disorder characterized by elevated serum urate due to purine metabolism dysfunction, affects 14.0% of Chinese adults (24.5% in men, 3.6% in women). Elevated serum urate leads to crystal deposition in joints, soft tissues, and kidneys, contributing not only to gout flares but also to renal and other organ damage. Although urate-lowering therapies (e.g., febuxostat, benzbromarone) effectively control serum urate, current guidelines do not recommend early pharmacological intervention for asymptomatic hyperuricemia due to safety concerns. Thus, additional strategies beyond lifestyle guidance are needed for this population.
Prior Research A prospective randomized study by the Affiliated Hospital of Qingdao University in 182 gout patients showed that a citrate mixture had comparable urate-lowering and urine alkalinization effects to sodium bicarbonate. After 3 months, the citrate effervescent tablet was superior in reducing hematuria and gout recurrence. Tart cherries, rich in anti-inflammatory and antioxidant anthocyanins, have been shown overseas to improve cardiovascular risk factors (blood pressure, cholesterol, blood glucose). The tart cherry citrate effervescent tablet enhances the original citrate mixture with increased citric acid and added tart cherry components.
A 24-week randomized, open-label, parallel-controlled trial in 282 male gout patients (fasting urine pH ≤6) demonstrated that the tart cherry citrate effervescent tablet had similar efficacy and safety to citrate mixture and sodium bicarbonate for urine alkalinization and serum urate lowering. However, it produced greater improvements in urinary albumin-to-creatinine ratio (UACR) and C-reactive protein (CRP), significantly reduced gout flare frequency, and improved metabolic parameters (systolic/diastolic blood pressure, fasting glucose, homeostasis model assessment-insulin resistance [HOMA-IR], total cholesterol).
Study Objectives To evaluate the efficacy and safety of tart cherry citrate effervescent tablet in participants with asymptomatic hyperuricemia.
Trial Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years, regardless of sex;
- •Meet the diagnostic criteria for primary hyperuricemia, with serum urate levels between 420 μmol/L and 540 μmol/L (for those without comorbidities) or between 420 μmol/L and 480 μmol/L (for those with at least one of the following comorbidities: hypertension, dyslipidemia, diabetes mellitus, obesity, stroke, coronary heart disease, heart failure, or CKD stage ≥2);
- •Participants with asymptomatic hyperuricemia who have not previously received urate-lowering therapy and have no history of acute gout flares;
- •Voluntarily participate in the study and provide written informed consent.
排除标准
- •Known allergy to any of the study medications, food products, or their components; current allergies; or known hypersensitivity;
- •Active liver disease or cirrhosis, or liver dysfunction with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal (ULN);
- •Acute infection or active gastrointestinal ulcers;
- •History of thyroid dysfunction;
- •Estimated glomerular filtration rate (eGFR) <60 mL/min;
- •Severe cardiac diseases, such as decompensated heart failure (NYHA class III or IV), unstable angina, or a history of myocardial infarction within the previous 12 months;
- •Renal cysts, medullary sponge kidney, or other obstructive nephropathies;
- •Rheumatoid arthritis requiring treatment or arthropathies due to other causes;
- •Current use of medications that affect urate levels, including febuxostat, allopurinol, benzbromarone, probenecid, azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, pyrazinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (>325 mg/day) or other salicylates, losartan, or intravenous colchicine;
- •Secondary hyperuricemia due to hematologic disorders, renal diseases, or radiotherapy/chemotherapy for malignancies;
- •Brain disorders with impaired judgment, or mental disorders that preclude cooperation;
- •Alcohol or substance abuse;
- •Participation in another clinical trial within the three months prior to screening;
- •Malignancy or active tuberculosis;
- •Presence of other concurrent conditions that, in the investigator's judgment, may affect the efficacy evaluation or result in poor compliance;
- •Use of glucocorticoids;
- •Any other reason that, in the investigator's judgment, makes the participant unsuitable for enrollment in this trial.
研究组 & 干预措施
Tart Cherry Citrate Effervescent Tablet
Lifestyle guidance + tart cherry citrate effervescent tablet 4.0 g twice daily
干预措施: tart cherry citrate effervescent table (Dietary Supplement)
Placebo Effervescent Tablet
Matching placebo effervescent tablet identical in appearance, taste, and preparation to the tart cherry citrate effervescent tablet but containing no active ingredients. Participants take 4.0 g (one tablet) dissolved in 200-250 mL of water twice daily (morning and evening), regardless of meals. Daily total water intake is controlled at 2000-2500 mL. The tablet is taken as an adjunct to lifestyle guidance.
干预措施: Placebo Control Group (Dietary Supplement)