Clinical trial NCT03218709: The Intervention of Multi-vitamin With Minerals to Hyperuricemia
Official title: Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperuricemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Serum uric acid
timeFrame: 1 year
Secondary outcomes:
measure: Serum IL-1
timeFrame: 1.5 years
measure: Serum IL-6
timeFrame: 1.5 years
measure: Serum IL-10
timeFrame: 1.5 years
measure: Serum TNF-α
timeFrame: 1.5 years
measure: Serum CRP
timeFrame: 1.5 years
measure: Serum c-peptide
timeFrame: 1.5 years
measure: Serum xanthine oxidase(XOD) activity
timeFrame: 1.5 years
measure: Serum phosphoribosyl pyrophosphate(PRPP)
timeFrame: 1.5 years
measure: Serum Glutamine(Glu)
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Nutrition,School of Public Health,Sun Yat-sen University
name: Min Xia, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: