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To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose multi-vitamins with minerals | Experimental | Generic name: High-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months |
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| Low-dose multi-vitamins with minerals | Experimental | Generic name: Low-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months |
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| Hypouricemic tablets | Active Comparator | Generic name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months |
|
| Placebo | Placebo Comparator | Generic name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose multi-vitamins with minerals | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum uric acid | Level of uric acid was described in μmol/L | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IL-1 | Inflammation condition，serum IL-1 was described in ng/l. | 1.5 years |
| Serum IL-6 | Inflammation condition, level of IL-6 was described in ng/l |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Guo, Ph.D | Contact | guoyi_019@126.com | ||
| Min Xia, Ph.D | Contact | xiamin@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Xia, Ph.D | Department of Nutrition,School of Public Health,Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
Do not share participants data
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008903 | Minerals |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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| Low-dose multi-vitamins with minerals | Combination Product | 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. |
|
| Hypouricemic tablets | Combination Product | The hypouricemic tablets contained skipjack,salvia and rosemary extract. |
|
| Placebo | Combination Product | The placebo tablets contained maltodextrin and tartrazine. |
|
| 1.5 years |
| Serum IL-10 | Inflammation condition, level of IL-10 was described in ng/l | 1.5 years |
| Serum TNF-α | Inflammation condition, level of TNF-α was described in ng/l | 1.5 years |
| Serum CRP | Inflammation condition, level of CRP was described in mg/l | 1.5 years |
| Serum c-peptide | Pancreas islets function, c-peptide was described in nmol/L. | 1.5 years |
| Serum xanthine oxidase(XOD) activity | Purine metabolism function, XOD activity was described in in U/ml. | 1.5 years |
| Serum phosphoribosyl pyrophosphate(PRPP) | Purine metabolism function, PRPP level was described in μmol/g Hb. | 1.5 years |
| Serum Glutamine(Glu) | Purine metabolism function, Glu level was described in μmol/L. | 1.5 years |