Hyperuricemia
Conditions
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.
Interventions
COMBINATION_PRODUCTHigh-dose multi-vitamins with minerals
The high-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.37mg,vitamin C 0.27mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively.
COMBINATION_PRODUCTLow-dose multi-vitamins with minerals
The low-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.20mg,vitamin C 0.50mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively.
COMBINATION_PRODUCTHypouricemic tablets
The hypouricemic tablets contained skipjack,salvia and rosemary extract.
COMBINATION_PRODUCTPlacebo
The placebo tablets contained maltodextrin and tartrazine.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum uric acid | 1 year | Level of uric acid was described in μmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum IL-6 | 1.5 years | Inflammation condition, level of IL-6 was described in ng/l |
| Serum IL-10 | 1.5 years | Inflammation condition, level of IL-10 was described in ng/l |
| Serum TNF-α | 1.5 years | Inflammation condition, level of TNF-α was described in ng/l |
| Serum CRP | 1.5 years | Inflammation condition, level of CRP was described in mg/l |
| Serum IL-1 | 1.5 years | Inflammation condition，serum IL-1 was described in ng/l. |
| Serum xanthine oxidase(XOD) activity | 1.5 years | Purine metabolism function, XOD activity was described in in U/ml. |
| Serum phosphoribosyl pyrophosphate(PRPP) | 1.5 years | Purine metabolism function, PRPP level was described in μmol/g Hb. |
| Serum Glutamine(Glu) | 1.5 years | Purine metabolism function, Glu level was described in μmol/L. |
| Serum c-peptide | 1.5 years | Pancreas islets function, c-peptide was described in nmol/L. |
Countries
China
Contacts
Primary ContactYi Guo, Ph.D
Backup ContactMin Xia, Ph.D
Outcome results
None listed