Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum uric acid
研究概览
简要总结
To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.
详细描述
Hyperuricemia is a type of metabolic diseases which caused by purine metabolic disorder and (or) uric acid excretion disorder. Uric acid is produced by cell metabolism and food purine metabolism as the end-point product. Excess alcohol and purine-rich food intake together with abnormal function of purine metabolic key enzyme are the main causes leading increasing serum level of uric acid. It has been a focus in nutritional area that a safer approach of preventing hyperuricemia by adjustment of nutritional intake. Primary studies found that proper supplement of microelements showed significant regulations in inflammation and oxidative stress induced by elevating level of uric acid. Therefore, this study will be conducted to test whether the supplement of multi-vitamins with minerals will lower the level of blood uric acid and improve the imbalance of microelement metabolism or not. The investigators will recruit 200 subjects of study who would be divided into four groups and accept intervention of high-dose multi-vitamins with minerals, low-dose multi-vitamins with minerals, hypouricemic tablets and placebo, respectively. After intervention of 3 or 6 months, serum uric acid and purine metabolism function will be detected. This study could provide references for illuminating the mechanism in purine metabolism and nutritional measures to control the pathological development of hyperuricemia.
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
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under the dietary pattern of normal intake of purine, the level of serum uric acid is higher than 420μmol/L for male or 360μmol/L for female (not be detected twice at the same day).
排除标准
- •Gouty arthritis, tophus or gouty nephropathy.
- •Complications including diabetes, cardiovascular diseases (angina, myocardial infarction) and so on.
- •Taken hypouricemic medicine in the last week before intervention, including allopurinol, benzbromarone, probenecid and so on.
- •Had an operation in the past year.
- •Malnutrition or severe obesity, BMI<18.5kg/m2 or >30.0 kg/m
- •Mental diseases, tumor, hepatic cirrhosis or other diseases that may interfere with the intervention.
- •Alcohol abuse (>80g/d)
研究组 & 干预措施
High-dose multi-vitamins with minerals
Generic name: High-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months
干预措施: High-dose multi-vitamins with minerals (Combination Product)
Low-dose multi-vitamins with minerals
Generic name: Low-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months
干预措施: Low-dose multi-vitamins with minerals (Combination Product)
Hypouricemic tablets
Generic name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months
干预措施: Hypouricemic tablets (Combination Product)
Placebo
Generic name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months
干预措施: Placebo (Combination Product)
结局指标
主要结局
Serum uric acid
时间窗: 1 year
Level of uric acid was described in μmol/L
次要结局
- Serum IL-1(1.5 years)
- Serum IL-10(1.5 years)
- Serum c-peptide(1.5 years)
- Serum xanthine oxidase(XOD) activity(1.5 years)
- Serum Glutamine(Glu)(1.5 years)
- Serum CRP(1.5 years)
- Serum IL-6(1.5 years)
- Serum TNF-α(1.5 years)
- Serum phosphoribosyl pyrophosphate(PRPP)(1.5 years)
研究者
Di Li
PhD
Sun Yat-sen University