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Trial registered on ANZCTR


Trial ID
ACTRN12605000021673
Ethics application status
Approved
Date submitted
8/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of natural seaweed extract (GFS) on mobilisation of human bone marrow stem cells and immune system activation
Scientific title
A randomised phase II study to evaluate the effects of natural seaweed extract (GFS) in normal volunteers on mobilising stem cells and activating the immune system.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal volunteers 83 0
Condition category
Condition code
Other 103 103 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Inflammatory and Immune System 104 104 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to look at the effects of ingesting seaweed fucoidan (GFS) on the mobilisation/release of haematopoeitic progenitor stem cells from bone marrow to the peripheral blood and to study its effects on modulating the immune system. This will be important in treatment following autologous transplantation, AIDS and cancer patients.

Investigational Arms:
1. 3g of 10% GFS/Day for 12 days
2. 3g of 75% GFS/Day for 12 days
3. G-CSF treatment
Intervention code [1] 4 0
Treatment: Other
Comparator / control treatment
Control arm:
3g of placebo fibers (guar gum) for 12 days
Control group
Placebo

Outcomes
Primary outcome [1] 129 0
To evaluate the effects of GFS (fucoidan) on the mobilization of haematopoietic progenitor stem cells
Timepoint [1] 129 0
After 12 days
Primary outcome [2] 130 0
To evaluate the effects of GFS (fucoidan) on the immune system modulation
Timepoint [2] 130 0
After 12 days
Primary outcome [3] 131 0
To evaluate the effects of GFS (fucoidan) on the level of SDF-1 in healthy subjects before and affter G-CSF treatment
Timepoint [3] 131 0
After 12 days
Secondary outcome [1] 292 0
N/A
Timepoint [1] 292 0

Eligibility
Key inclusion criteria
Volunteers criteria:Healthy adults, non-smokers, no treatment in the last 30 days including contraceptive pills, no history of thyroid abnormalities, no sulpher allergy. Withdrawal criteria:development of thyroid abnormalities, volunteer requestG-CSF subjects:normal adult subjects, suitable for G-CSF treatment, about to recieve G-CSF
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 138 0
University
Name [1] 138 0
University of Tasmania
Address [1] 138 0
Country [1] 138 0
Australia
Primary sponsor type
University
Name
UTas
Address
Country
Australia
Secondary sponsor category [1] 99 0
None
Name [1] 99 0
N/A
Address [1] 99 0
Country [1] 99 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36234 0
Address 36234 0
Country 36234 0
Phone 36234 0
Fax 36234 0
Email 36234 0
Contact person for public queries
Name 9193 0
Mohammad Irhimeh
Address 9193 0
43 Collins St
Hobart TAS 7001
Country 9193 0
Australia
Phone 9193 0
+61 3 62264846
Fax 9193 0
+61 3 62264894
Email 9193 0
mirhimeh@utas.edu.au
Contact person for scientific queries
Name 121 0
Mohammad Irhimeh
Address 121 0
43 Collins St
Hobart 7001 TAS
Country 121 0
Australia
Phone 121 0
+61 3 62264846
Fax 121 0
+61 3 62264894
Email 121 0
mirhimeh@utas.edu.au