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The Intervention of Multi-vitamin With Minerals to Hyperuricemia

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ClinicalTrials.gov Identifier: NCT03218709
Recruitment Status : Unknown
Verified July 2017 by Di Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Di Li, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Hyperuricemia Combination Product: High-dose multi-vitamins with minerals Combination Product: Low-dose multi-vitamins with minerals Combination Product: Hypouricemic tablets Combination Product: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: 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
Combination Product: High-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.

Experimental: 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
Combination Product: Low-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.

Active Comparator: Hypouricemic tablets
Generic name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months
Combination Product: Hypouricemic tablets
The hypouricemic tablets contained skipjack,salvia and rosemary extract.

Placebo Comparator: Placebo
Generic name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months
Combination Product: Placebo
The placebo tablets contained maltodextrin and tartrazine.




Primary Outcome Measures :
  1. Serum uric acid [ Time Frame: 1 year ]
    Level of uric acid was described in μmol/L


Secondary Outcome Measures :
  1. Serum IL-1 [ Time Frame: 1.5 years ]
    Inflammation condition,serum IL-1 was described in ng/l.

  2. Serum IL-6 [ Time Frame: 1.5 years ]
    Inflammation condition, level of IL-6 was described in ng/l

  3. Serum IL-10 [ Time Frame: 1.5 years ]
    Inflammation condition, level of IL-10 was described in ng/l

  4. Serum TNF-α [ Time Frame: 1.5 years ]
    Inflammation condition, level of TNF-α was described in ng/l

  5. Serum CRP [ Time Frame: 1.5 years ]
    Inflammation condition, level of CRP was described in mg/l

  6. Serum c-peptide [ Time Frame: 1.5 years ]
    Pancreas islets function, c-peptide was described in nmol/L.

  7. Serum xanthine oxidase(XOD) activity [ Time Frame: 1.5 years ]
    Purine metabolism function, XOD activity was described in in U/ml.

  8. Serum phosphoribosyl pyrophosphate(PRPP) [ Time Frame: 1.5 years ]
    Purine metabolism function, PRPP level was described in μmol/g Hb.

  9. Serum Glutamine(Glu) [ Time Frame: 1.5 years ]
    Purine metabolism function, Glu level was described in μmol/L.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218709


Contacts
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Contact: Yi Guo, Ph.D guoyi_019@126.com
Contact: Min Xia, Ph.D xiamin@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Min Xia, Ph.D       xiamin@mail.sysu.edu.cn   
Contact: Yi Guo, Ph.D       guoyi_019@126.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Min Xia, Ph.D Department of Nutrition,School of Public Health,Sun Yat-sen University

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Responsible Party: Di Li, PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03218709     History of Changes
Other Study ID Numbers: ZXYZM-6
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do not share participants data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs