ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Alternative and Complementary Medicine

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]

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]

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]

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]

Analyse concentration of endogenous glucosamine (GlcNend) in plasma for each individual.

Timepoint [1]

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

Sex

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

1/06/2018

Actual

Date of last participant enrolment

Anticipated

1/12/2018

Actual

Date of last data collection

Anticipated

20/12/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Tasmania

Address [1]

Churchill Avenue, Sandy Bay, Hobart, Tasmania, 7005

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Royal Hobart Hospital

Address [2]

Royal Hobart Hospital Research Foundation grant
Ground floor, 22 Elizabeth Street
Hobart, Tasmania 7000

Country [2]

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]

Individual

Name [1]

Dr Rahul Patel

Address [1]

Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Private Bag 26, Hobart, Tasmania, 7001.

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Tasmania Health and Medical Human Research Ethics Committee (EC00337)

Ethics committee address [1]

Office of Research Services, University of Tasmania, Private Bag 1, Hobart, TAS, 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2017

Approval date [1]

Ethics approval number [1]

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

Prof Gregory Peterson

Address

Faculty of Health, Private Bag 26, University of Tasmania. Hobart, Tasmania 7001.

Country

Australia

Phone

+61362262197

Fax

[email protected]

Contact person for public queries

Name

Ms Chhavi Asthana

Address

Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Private Bag 26, Hobart, Tasmania, 7001.

Country

Australia

Phone

+61411053161

Fax

[email protected]

Contact person for scientific queries

Name

Dr Rahul Patel

Address

Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Private Bag 26, Hobart, Tasmania, 7001.

Country

Australia

Phone

+61362261079

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Other Details
23586	Other		https://doi.org/10.1093/rheumatology/keaa418
23587	Ethical approval	-999999
23818	Other			Pre-print of the following publication. Journal: ... [More Details]

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4690	Study results article	Yes		The publication citation is given below. Chhavi A... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Variation in the pharmacokinetics of glucosamine in healthy individuals.	2021	https://dx.doi.org/10.1093/rheumatology/keaa418

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

Trial Review

Documents added manually

Documents added automatically