Trial Review

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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 2871 0
Vascular Dysfunction 2872 0
Condition category
Condition code
Renal and Urogenital 3007 3007 0 0
Kidney disease
Cardiovascular 3008 3008 0 0
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] 2604 0
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] 3889 0
The measurement of oxidative stress using the markers 8-F2-isoprostane (plasma and erythrocytes) and antibodies against oxidised low density lipoprotein (plasma)
Timepoint [1] 3889 0
Baseline, 6 and 12 months after commencement of intervention
Primary outcome [2] 3890 0
The measurement of endothelial function using the brachial artery reactivity (BAR) technique
Timepoint [2] 3890 0
Baseline, 6 and 12 months after commencement of intervention
Primary outcome [3] 3891 0
Arterial stiffness by measuring pulse wave velocity and augmentation index
Timepoint [3] 3891 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [1] 6539 0
Erythrocyte glutathione peroxidase
Timepoint [1] 6539 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [2] 6540 0
Erythrocyte superoxide dismutase
Timepoint [2] 6540 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [3] 6541 0
Erythrocyte catalase
Timepoint [3] 6541 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [4] 6542 0
Erythrocyte glucose-6-phosphate dehydrogeanse
Timepoint [4] 6542 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [5] 6543 0
Erythrocyte glutathione (reduced)
Timepoint [5] 6543 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [6] 6544 0
Erythrocyte glutatione (oxidised)
Timepoint [6] 6544 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [7] 6545 0
Erythrocyte alpha tocopherol
Timepoint [7] 6545 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [8] 6546 0
Erythrocyte carotenoids (total)
Timepoint [8] 6546 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [9] 6547 0
Erythrocyte methemoglobin
Timepoint [9] 6547 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [10] 6548 0
Erythrocyte malondialdehyde
Timepoint [10] 6548 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [11] 6549 0
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] 6549 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [12] 6550 0
Plasma glutatione peroxidase
Timepoint [12] 6550 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [13] 6551 0
Plasma catalase
Timepoint [13] 6551 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [14] 6552 0
Plasma alpha tocopherol
Timepoint [14] 6552 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [15] 6553 0
Plasma carotenoids (total)
Timepoint [15] 6553 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [16] 6554 0
Carotid artery intima media thickness will be measured by a trained technician using ultrasound of the carotid artery.
Timepoint [16] 6554 0
Baseline, 6 and 12 months after commencement of intervention
Secondary outcome [17] 6555 0
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] 6555 0
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] 3187 0
Hospital
Name [1] 3187 0
Renal Research Tasmania
Country [1] 3187 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles Street
Launceston
Tasmania 7250
Country
Australia
Secondary sponsor category [1] 2857 0
Commercial sector/Industry
Name [1] 2857 0
Cyanotech Corporation
Address [1] 2857 0
73-4460 Queen Kaahuhamu Hwy, Ste 102
Kailua-Kona
Hawaii 96740
Country [1] 2857 0
United States of America
Other collaborator category [1] 237 0
University
Name [1] 237 0
University of Queensland
Address [1] 237 0
School of Human Movement Studies
St. Lucia
Queensland
Country [1] 237 0
Australia
Other collaborator category [2] 238 0
University
Name [2] 238 0
University of Tasmania
Address [2] 238 0
School of Human Life Science
Launceston
Tasmania 7250
Country [2] 238 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5173 0
The Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 5173 0
Private Bag 01
Hobart
Tasmania 7001
Ethics committee country [1] 5173 0
Australia
Date submitted for ethics approval [1] 5173 0
Approval date [1] 5173 0
23/05/2006
Ethics approval number [1] 5173 0
H 8414

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28403 0
Address 28403 0
Country 28403 0
Phone 28403 0
Fax 28403 0
Email 28403 0
Contact person for public queries
Name 11560 0
Prof Rob Fassett
Address 11560 0
Launceston General Hospital
Charles Street
Launceston
Tasmania 7250
Country 11560 0
Australia
Phone 11560 0
03 6348 7111
Fax 11560 0
03 6348 7090
Email 11560 0
[email protected]
Contact person for scientific queries
Name 2488 0
Assoc. Prof. Jeff Coombes
Address 2488 0
University of Queensland
School of Human Movement Studies
St. Lucia
Queensland
Country 2488 0
Australia
Phone 2488 0
07 3365 6767
Fax 2488 0
07 3365 6877
Email 2488 0
[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
SourceTitleYear of PublicationDOI
Dimensions AIAstaxanthin vs placebo on arterial stiffness, oxidative stress and inflammation in renal transplant patients (Xanthin): a randomised controlled trial2008https://doi.org/10.1186/1471-2369-9-17
Dimensions AIPentraxin-3 levels in graft-versus-host disease during allogeneic hematopoietic stem cell transplantation2016https://doi.org/10.1016/j.exphem.2016.07.002
EmbaseMitochondria-targeted antioxidants for the treatment of cardiovascular disorders.2017https://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.