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The Intervention of Multi-vitamin With Minerals to Hyperuricemia

Primary Purpose

Hyperuricemia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
High-dose multi-vitamins with minerals
Low-dose multi-vitamins with minerals
Hypouricemic tablets
Placebo
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

High-dose multi-vitamins with minerals

Low-dose multi-vitamins with minerals

Hypouricemic tablets

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Serum uric acid
Level of uric acid was described in μmol/L

Secondary Outcome Measures

Serum IL-1
Inflammation condition,serum IL-1 was described in ng/l.
Serum IL-6
Inflammation condition, level of IL-6 was described in ng/l
Serum IL-10
Inflammation condition, level of IL-10 was described in ng/l
Serum TNF-α
Inflammation condition, level of TNF-α was described in ng/l
Serum CRP
Inflammation condition, level of CRP was described in mg/l
Serum c-peptide
Pancreas islets function, c-peptide was described in nmol/L.
Serum xanthine oxidase(XOD) activity
Purine metabolism function, XOD activity was described in in U/ml.
Serum phosphoribosyl pyrophosphate(PRPP)
Purine metabolism function, PRPP level was described in μmol/g Hb.
Serum Glutamine(Glu)
Purine metabolism function, Glu level was described in μmol/L.

Full Information

First Posted
March 22, 2017
Last Updated
July 13, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03218709
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose multi-vitamins with minerals
Arm Type
Experimental
Arm Description
Generic name: High-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months
Arm Title
Low-dose multi-vitamins with minerals
Arm Type
Experimental
Arm Description
Generic name: Low-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months
Arm Title
Hypouricemic tablets
Arm Type
Active Comparator
Arm Description
Generic name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Generic name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months
Intervention Type
Combination Product
Intervention Name(s)
High-dose multi-vitamins with minerals
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Low-dose multi-vitamins with minerals
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Hypouricemic tablets
Intervention Description
The hypouricemic tablets contained skipjack,salvia and rosemary extract.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
The placebo tablets contained maltodextrin and tartrazine.
Primary Outcome Measure Information:
Title
Serum uric acid
Description
Level of uric acid was described in μmol/L
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Serum IL-1
Description
Inflammation condition,serum IL-1 was described in ng/l.
Time Frame
1.5 years
Title
Serum IL-6
Description
Inflammation condition, level of IL-6 was described in ng/l
Time Frame
1.5 years
Title
Serum IL-10
Description
Inflammation condition, level of IL-10 was described in ng/l
Time Frame
1.5 years
Title
Serum TNF-α
Description
Inflammation condition, level of TNF-α was described in ng/l
Time Frame
1.5 years
Title
Serum CRP
Description
Inflammation condition, level of CRP was described in mg/l
Time Frame
1.5 years
Title
Serum c-peptide
Description
Pancreas islets function, c-peptide was described in nmol/L.
Time Frame
1.5 years
Title
Serum xanthine oxidase(XOD) activity
Description
Purine metabolism function, XOD activity was described in in U/ml.
Time Frame
1.5 years
Title
Serum phosphoribosyl pyrophosphate(PRPP)
Description
Purine metabolism function, PRPP level was described in μmol/g Hb.
Time Frame
1.5 years
Title
Serum Glutamine(Glu)
Description
Purine metabolism function, Glu level was described in μmol/L.
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Guo, Ph.D
Email
guoyi_019@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Min Xia, Ph.D
Email
xiamin@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xia, Ph.D
Organizational Affiliation
Department of Nutrition,School of Public Health,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Xia, Ph.D
Email
xiamin@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yi Guo, Ph.D
Email
guoyi_019@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Do not share participants data

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The Intervention of Multi-vitamin With Minerals to Hyperuricemia

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