NCT03218709

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

March 22, 2017

Last Update Submit

July 13, 2017

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Serum uric acid

    Level of uric acid was described in μmol/L

    1 year

Secondary Outcomes (9)

  • Serum IL-1

    1.5 years

  • Serum IL-6

    1.5 years

  • Serum IL-10

    1.5 years

  • Serum TNF-α

    1.5 years

  • Serum CRP

    1.5 years

  • +4 more secondary outcomes

Study Arms (4)

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

Combination Product: High-dose multi-vitamins with minerals

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

Combination Product: Low-dose multi-vitamins with minerals

Hypouricemic tablets

ACTIVE COMPARATOR

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

Combination Product: Hypouricemic tablets

Placebo

PLACEBO COMPARATOR

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

Combination Product: Placebo

Interventions

High-dose multi-vitamins with mineralsCOMBINATION_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.

High-dose multi-vitamins with minerals
Low-dose multi-vitamins with mineralsCOMBINATION_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.

Low-dose multi-vitamins with minerals
Hypouricemic tabletsCOMBINATION_PRODUCT

The hypouricemic tablets contained skipjack,salvia and rosemary extract.

Hypouricemic tablets
PlaceboCOMBINATION_PRODUCT

The placebo tablets contained maltodextrin and tartrazine.

Placebo

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Hyperuricemia

Interventions

Minerals

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Min Xia, Ph.D

    Department of Nutrition,School of Public Health,Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Guo, Ph.D

CONTACT

guoyi_019@126.com

Min Xia, Ph.D

CONTACT

xiamin@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 22, 2017

First Posted

July 14, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Do not share participants data

Locations

CN(1)