The Intervention of Multi-vitamin With Minerals to Hyperuricemia

July 13, 2017 updated by: Di Li, Sun Yat-sen University

Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum uric acid
Time Frame: 1 year
Level of uric acid was described in μmol/L
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum IL-1
Time Frame: 1.5 years
Inflammation condition，serum IL-1 was described in ng/l.
1.5 years
Serum IL-6
Time Frame: 1.5 years
Inflammation condition, level of IL-6 was described in ng/l
1.5 years
Serum IL-10
Time Frame: 1.5 years
Inflammation condition, level of IL-10 was described in ng/l
1.5 years
Serum TNF-α
Time Frame: 1.5 years
Inflammation condition, level of TNF-α was described in ng/l
1.5 years
Serum CRP
Time Frame: 1.5 years
Inflammation condition, level of CRP was described in mg/l
1.5 years
Serum c-peptide
Time Frame: 1.5 years
Pancreas islets function, c-peptide was described in nmol/L.
1.5 years
Serum xanthine oxidase(XOD) activity
Time Frame: 1.5 years
Purine metabolism function, XOD activity was described in in U/ml.
1.5 years
Serum phosphoribosyl pyrophosphate(PRPP)
Time Frame: 1.5 years
Purine metabolism function, PRPP level was described in μmol/g Hb.
1.5 years
Serum Glutamine(Glu)
Time Frame: 1.5 years
Purine metabolism function, Glu level was described in μmol/L.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Xia, Ph.D, Department of Nutrition,School of Public Health,Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZXYZM-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Do not share participants data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperuricemia

Clinical Trials on High-dose multi-vitamins with minerals

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings