ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000159358

Ethics application status

Approved

Date submitted

20/03/2008

Date registered

3/04/2008

Date last updated

3/04/2008

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of antioxidant supplementation with Astaxanthin on blood vessels in renal transplant patients

Scientific title

Effects of supplementation with Astaxanthin on oxidative stress and vascular structure and function in renal transplant patients

Universal Trial Number (UTN)

Trial acronym

Xanthin Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Renal Transplantation

Vascular Dysfunction

Condition category

Condition code

Renal and Urogenital

Kidney disease

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Astaxanthin 4 mg tablets, 3 tablets daily over 12 months

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The placebo is a non hazardous placebo gel capsule, identical looking to the actual treatment. Administration is oral, 3 tablets daily for 12 months.

Control group

Placebo

Outcomes

Primary outcome [1]

The measurement of oxidative stress using the markers 8-F2-isoprostane (plasma and erythrocytes) and antibodies against oxidised low density lipoprotein (plasma)

Timepoint [1]

Baseline, 6 and 12 months after commencement of intervention

Primary outcome [2]

The measurement of endothelial function using the brachial artery reactivity (BAR) technique

Timepoint [2]

Baseline, 6 and 12 months after commencement of intervention

Primary outcome [3]

Arterial stiffness by measuring pulse wave velocity and augmentation index

Timepoint [3]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [1]

Erythrocyte glutathione peroxidase

Timepoint [1]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [2]

Erythrocyte superoxide dismutase

Timepoint [2]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [3]

Erythrocyte catalase

Timepoint [3]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [4]

Erythrocyte glucose-6-phosphate dehydrogeanse

Timepoint [4]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [5]

Erythrocyte glutathione (reduced)

Timepoint [5]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [6]

Erythrocyte glutatione (oxidised)

Timepoint [6]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [7]

Erythrocyte alpha tocopherol

Timepoint [7]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [8]

Erythrocyte carotenoids (total)

Timepoint [8]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [9]

Erythrocyte methemoglobin

Timepoint [9]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [10]

Erythrocyte malondialdehyde

Timepoint [10]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [11]

Respective immunosupressant: Data will be collected on what Immunosuppressant the participants are on. Blood levels of the immunosuppressant are measured to ensure that levels remain within desired limits.

Timepoint [11]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [12]

Plasma glutatione peroxidase

Timepoint [12]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [13]

Plasma catalase

Timepoint [13]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [14]

Plasma alpha tocopherol

Timepoint [14]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [15]

Plasma carotenoids (total)

Timepoint [15]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [16]

Carotid artery intima media thickness will be measured by a trained technician using ultrasound of the carotid artery.

Timepoint [16]

Baseline, 6 and 12 months after commencement of intervention

Secondary outcome [17]

Myocardial function will be measured using transthoracic echocardiography in the side-lying position at rest. Left Ventricular (LV) end systolic and end diastolic dimensions and the thickness of the interventricular septum and posterior wall will be measured. Mitral regurgitation will be evaluated and assessed. Ejection fraction will be measured.

Timepoint [17]

Baseline, 6 and 12 months after commencement of intervention

Eligibility

Key inclusion criteria

Have undergone a renal transplant

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Individuals currently taking antioxidant supplements or have AV fistulas in both arms or are unable to be given anginine or participation or proposed participation in another clinical investigational drug study within 30 days prior to study entry.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients from renal transplant clincs are approached to participate in the study. A full informed consent process is performed before the subjects give written consent to participate in the study. The person consenting the patient is not aware of the group the participant will be allocated to. The allocation is done by contacting the holder of the allocation schedule at a central administration site in a different department of the hospital.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation and concealment is done by the Pharmacy Department at the Launceston General Hospital according to established protocols. A blocked randomisation is used by using a randomisation table created by a computer software. A stratified allocation is used according to the immunosupressant type the participants are taking.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Subjects will be stratified according to immunosuppressive therapy (4 groups)

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/09/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

44

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Renal Research Tasmania

Address [1]

Launceston General Hospital
Charles Street
Launceston
Tasmania 7250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

Charles Street
Launceston
Tasmania 7250

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Cyanotech Corporation

Address [1]

73-4460 Queen Kaahuhamu Hwy, Ste 102
Kailua-Kona
Hawaii 96740

Country [1]

United States of America

Other collaborator category [1]

University

Name [1]

University of Queensland

Address [1]

School of Human Movement Studies
St. Lucia
Queensland

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Tasmania

Address [2]

School of Human Life Science
Launceston
Tasmania 7250

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Human Research Ethics Committee (Tasmania) Network

Ethics committee address [1]

Private Bag 01
Hobart
Tasmania    7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/05/2006

Ethics approval number [1]

H 8414

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Prof Rob Fassett

Address

Launceston General Hospital
Charles Street
Launceston
Tasmania 7250

Country

Australia

Phone

03 6348 7111

Fax

03 6348 7090

Email

[email protected]

Contact person for scientific queries

Name

Assoc. Prof. Jeff Coombes

Address

University of Queensland
School of Human Movement Studies
St. Lucia
Queensland

Country

Australia

Phone

07 3365 6767

Fax

07 3365 6877

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Astaxanthin vs placebo on arterial stiffness, oxidative stress and inflammation in renal transplant patients (Xanthin): a randomised controlled trial	2008	https://doi.org/10.1186/1471-2369-9-17
Dimensions AI	Pentraxin-3 levels in graft-versus-host disease during allogeneic hematopoietic stem cell transplantation	2016	https://doi.org/10.1016/j.exphem.2016.07.002
Embase	Mitochondria-targeted antioxidants for the treatment of cardiovascular disorders.	2017	https://dx.doi.org/10.1007/978-3-319-55330-6_32

N.B. These documents automatically identified may not have been verified by the study sponsor.