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Trial registered on ANZCTR


Registration number
ACTRN12618000699268p
Ethics application status
Submitted, not yet approved
Date submitted
17/04/2018
Date registered
30/04/2018
Date last updated
30/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysing variation in the absorption and elimination of glucosamine among healthy individuals to investigate possible reasons for inconsistent clinical outcomes to glucosamine therapy
Scientific title
Analysing variation in the rate of absorption and elimination of glucosamine among healthy individuals
Secondary ID [1] 294646 0
Nil Known
Universal Trial Number (UTN)
Nil Known
Trial acronym
Nil Known
Linked study record
Nil Known

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 305873 0
Condition category
Condition code
Musculoskeletal 305071 305071 0 0
Osteoarthritis
Alternative and Complementary Medicine 305072 305072 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two Australian brands have chosen to be included in the present study: Blackmores Glucosamine and DONA glucosamine.
For Blackmores Glucosamine:
- the dose administered: 1500mg once-a-day
- the duration of administration: six days
- the mode of administration: an oral tablet
For DONA glucosamine:
- the dose administered: 1500mg once-a-day
- the duration of administration will be six days
- the mode of administration: soluble oral powder
Each participant will be provided with seven tablets of Blackmores brand in a seven-day pill/medicine-organiser box and seven sachets of DONA brand in a plastic container. At the end of the study, the participant will be asked to return the pill/medicine-organiser box and plastic container and the remaining tablets and sachets will be counted to find out if the participant has missed any dose. The participant will be asked to take glucosamine approximately at the same time for each day of the study. The participants will also be provided with a diary in which they will write the time of glucosamine ingestion for each day. The participants will return the diary at the end of the study.

Each brand will be taken separately for six days with a five day washout period between the ingestion of two brands.
The total duration of this study is 17 days.

Blackmores brand of glucosamine will be ingested by the participants for six consecutive days (from day-1 to day-6).

Washout period: The participant will not take glucosamine for the next five consecutive days (from day-7 to day-11) to undergo a washout period. This will allow for the elimination of glucosamine from the bloodstream.

The DONA brand of glucosamine will be ingested by individuals from day-12 to day-17,

Glucosamine is expected reach steady state plasma concentration well within five days of dosing-hence taking the blood sample for analysis on the sixth day (day-6 and day-17) of dosing.
Intervention code [1] 299867 0
Treatment: Other
Comparator / control treatment
DONA glucosamine:
- the dose administered: 1500mg once-a-day
- the duration of administration will be six days
- the mode of administration: soluble oral powder
Control group
Active

Outcomes
Primary outcome [1] 304246 0
Analyse % coefficient of variation in the area under the plasma concentration versus time curve (AUCss), minimum plasma concentration (Css min) of glucosamine, the elimination rate constant (Kel), maximum plasma concentration (Css max) and time to reach Css max (Tss max) of glucosamine at steady-state for both Blackmores and DONA brand to determine inter-individual variability in the extent and rate of absorption of glucosamine corresponding to either of the two brands.
Analyse variation in the elimination rate constant (Kel) for the two brands in a single individual.
Timepoint [1] 304246 0
Glucosamine is expected to reach steady-state plasma concentration well within five days of dosing-hence taking a blood sample for analysis on the sixth day (day-6 and day-17) of dosing.
The blood sample of the participants will be collected at steady state or on the sixth day of dosing, just before the ingestion and then at 1, 1.5, 2, 3, 4, 5, 6, 10 and 12 hours after ingesting the scheduled dose of Blackmores brand on day-6 as well as just before and then after ingesting the scheduled dose of DONA brand on day-17.
The series of blood samples collected on each day will be analysed to determine the area under the plasma concentration versus time curve (AUCss), the elimination rate constant (Kel), maximum plasma concentration (Css max), minimum plasma concentration (Css min) of glucosamine and time to reach Css max (Tss max) of glucosamine at steady-state for each brand.
Secondary outcome [1] 343896 0
Analyse concentration of endogenous glucosamine (GlcNend) in plasma for each individual.
Timepoint [1] 343896 0
The blood sample of the participants will be collected on day-1, just before the ingestion of the first dose of Blackmores brand.

Eligibility
Key inclusion criteria
Individuals will be included if they are:
a. At least 18 years of age
b. Healthy individuals
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded if they are:
a. Taking glucosamine supplement
b. Women who are pregnant or breastfeeding
c. Have shellfish allergy or allergy to glucosamine
d. Suffering from any chronic medical condition/s including cancer, heart disease, asthma, diabetes and/or renal impairment
e. Taking any regular medication/s

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis
This is a control pilot study that aims to analyse whether there is a substantial difference in absorption of glucosamine among healthy individuals. According to the Therapeutics Goods Administration (TGA) , at least 12 participants are required to perform a biopharmaceutics/bioequivalence study; however, we aim to recruit 24 healthy participants. This approach to include sufficiently higher than the required number of participants is suggested by TGA as an acceptable way to manage the dropouts during the study period.

Recruitment
Recruitment status
Not yet 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)
TAS

Funding & Sponsors
Funding source category [1] 298225 0
University
Name [1] 298225 0
University of Tasmania
Address [1] 298225 0
Churchill Avenue, Sandy Bay, Hobart, Tasmania, 7005
Country [1] 298225 0
Australia
Funding source category [2] 298239 0
Hospital
Name [2] 298239 0
Royal Hobart Hospital
Address [2] 298239 0
Royal Hobart Hospital Research Foundation grant
Ground floor, 22 Elizabeth Street
Hobart, Tasmania 7000
Country [2] 298239 0
Australia
Primary sponsor type
Individual
Name
Prof Gregory Peterson
Address
Faculty of Health, Bag 26, University of Tasmania. Hobart, Tasmania, 7001.
Country
Australia
Secondary sponsor category [1] 297358 0
Individual
Name [1] 297358 0
Dr Rahul Patel
Address [1] 297358 0
Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Private Bag 26, Hobart, Tasmania, 7001.
Country [1] 297358 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299234 0
Tasmania Health and Medical Human Research Ethics Committee (EC00337)
Ethics committee address [1] 299234 0
Office of Research Services, University of Tasmania, Private Bag 1, Hobart, TAS, 7001
Ethics committee country [1] 299234 0
Australia
Date submitted for ethics approval [1] 299234 0
02/11/2017
Approval date [1] 299234 0
Ethics approval number [1] 299234 0

Summary
Brief summary
Glucosamine is used for the management of osteoarthritis. It shows inconsistent clinical outcomes in patients. Therefore, we propose that one possible explanation for the observed inconsistent clinical outcomes is variable inter-patient bioavailability of oral glucosamine.
To test our hypothesis, we will recruit 24 healthy adult individuals, who will take two brands (Blackmores and DONA) of glucosamine supplements individually for total six days to reach a steady-state plasma concentration of glucosamine. On the sixth (last) day of dosing of each brand, we will collect their blood samples just before ingestion and then at 1, 1.5, 2, 3, 4, 5, 6, 10 and 12 hours after the ingestion of the last scheduled dose to analyse pharmacokinetic parameters at steady-state, including minimum, maximum and average plasma concentration. We will compare the obtained pharmacokinetic parameters to estimate the variation in absorption of glucosamine among the participants and across the two brands.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79746 0
Prof Gregory Peterson
Address 79746 0
Faculty of Health, Private Bag 26, University of Tasmania. Hobart, Tasmania 7001.
Country 79746 0
Australia
Phone 79746 0
+61362262197
Fax 79746 0
Email 79746 0
G.Peterson@utas.edu.au
Contact person for public queries
Name 79747 0
Ms Chhavi Asthana
Address 79747 0
Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Private Bag 26, Hobart, Tasmania, 7001.
Country 79747 0
Australia
Phone 79747 0
+61411053161
Fax 79747 0
Email 79747 0
Chhavi.Asthana@utas.edu.au
Contact person for scientific queries
Name 79748 0
Dr Rahul Patel
Address 79748 0
Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Private Bag 26, Hobart, Tasmania, 7001.
Country 79748 0
Australia
Phone 79748 0
+61362261079
Fax 79748 0
Email 79748 0
Rahul.Patel@utas.edu.au

No data has been provided for results reporting
Summary results
Not applicable