NCT02797028

Brief Summary

The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.

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
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

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, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

May 12, 2016

Last Update Submit

June 7, 2016

Conditions

Cardiovascular Disease

Keywords

Hyperuricemiaendothelial functionanthocyanidins

Outcome Measures

Primary Outcomes (1)

  • Measurement of serum uric acid levels in all patients

    Serum uric acid (mg/dl) is determined by Uric Acid kit on an automated system.

    up to 1 months

Secondary Outcomes (1)

  • Measurement of advanced glycation end products and its receptor level in all patients

    up to 2 months

Study Arms (3)

Placebo capsule

PLACEBO COMPARATOR

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule

Dietary Supplement: Placebo capsule

Anthocyanidins capsule

EXPERIMENTAL

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule.

Dietary Supplement: Anthocyanidins capsule

Allopurinol

EXPERIMENTAL

The experimental group taking allopurinol.

Drug: Allopurinol

Interventions

Anthocyanidins capsuleDIETARY_SUPPLEMENT

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Anthocyanidins capsule
Placebo capsuleDIETARY_SUPPLEMENT

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Placebo capsule
AllopurinolDRUG

Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

Allopurinol

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Serum uric acid \>420μmol/L (7mg/dL) in male, \>360μmol/L (6mg/dL) in female identified as hyperuricemia patients.

You may not qualify if:

  • Age more than 60 years and less than 30 years old;
  • acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Guangzhou Military Command of People's Liberation Army

Guangzhou, Guangdong, 020, China

RECRUITING

Related Publications (6)

  • Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.

    PMID: 15198963BACKGROUND

  • Gimbrone MA Jr. Endothelial dysfunction and atherosclerosis. J Card Surg. 1989 Jun;4(2):180-3. doi: 10.1111/j.1540-8191.1989.tb00275.x.

    PMID: 2519996BACKGROUND

  • Verma S, Anderson TJ. Fundamentals of endothelial function for the clinical cardiologist. Circulation. 2002 Feb 5;105(5):546-9. doi: 10.1161/hc0502.104540. No abstract available.

    PMID: 11827916BACKGROUND

  • D'Marco L, Garcia I, Vega C. [Uric acid, atherosclerosis and vascular calcifications in chronic kidney disease]. Invest Clin. 2012 Mar;53(1):52-9. Spanish.

    PMID: 22524108BACKGROUND

  • Feig DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N Engl J Med. 2008 Oct 23;359(17):1811-21. doi: 10.1056/NEJMra0800885. No abstract available.

    PMID: 18946066BACKGROUND

  • Li C, Han L, Levin AM, Song H, Yan S, Wang Y, Wang Y, Meng D, Lv S, Ji Y, Xu X, Liu X, Wang Y, Zhou L, Miao Z, Mi QS. Multiple single nucleotide polymorphisms in the human urate transporter 1 (hURAT1) gene are associated with hyperuricaemia in Han Chinese. J Med Genet. 2010 Mar;47(3):204-10. doi: 10.1136/jmg.2009.068619. Epub 2009 Oct 14.

    PMID: 19833602BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHyperuricemia

Interventions

AnthocyaninsAllopurinol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological FactorsPurines

Central Study Contacts

Hui Dai

CONTACT

020-36653321daihui66@sina.com

Yuan Zhang

CONTACT

020-616535661035834805@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 13, 2016

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2017

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

CN(1)