The Intervention of Multi-vitamin With Minerals to Hyperuricemia

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Hyperuricemia

Treatments: Combination Product: High-dose multi-vitamins with minerals; Combination Product: Hypouricemic tablets; Combination Product: Low-dose multi-vitamins with minerals; Combination Product: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03218709

ZXYZM-6

Details and patient eligibility

About

To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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/m2.
• Mental diseases, tumor, hepatic cirrhosis or other diseases that may interfere with the intervention.
• Alcohol abuse (>80g/d)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups, including a placebo group

High-dose multi-vitamins with minerals

Experimental group

Description:

Generic name: High-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months

Treatment:

Combination Product: High-dose multi-vitamins with minerals

Low-dose multi-vitamins with minerals

Experimental group

Description:

Generic name: Low-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months

Treatment:

Combination Product: Low-dose multi-vitamins with minerals

Hypouricemic tablets

Active Comparator group

Description:

Generic name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months

Treatment:

Combination Product: Hypouricemic tablets

Placebo

Placebo Comparator group

Description:

Generic name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months

Treatment:

Combination Product: Placebo