Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000168954
Ethics application status
Approved
Date submitted
9/02/2011
Date registered
11/02/2011
Date last updated
20/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Oral Glucosamine Supplementation on Young Adults Experiencing Mild, Undiagnosed Knee Pain.
Scientific title
In young adults experiencing mild, undiagnosed knee pain, is oral Glucosamine sulphate more effective than a placebo in reducing joint pain and improving function?
Secondary ID [1] 253577 0
Nil
Universal Trial Number (UTN)
U1111-1119-3702
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Undiagnosed knee pain 261133 0
Condition category
Condition code
Musculoskeletal 259288 259288 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration of a glucosamine sulphate containing product (Pharmafoods Chondrotabs), containing:
Glucosamine sulphate-potassium chloride (664mg), Chondroitin sulphate (400mg), and Dimethyl sulphone (400mg)

The placebo group will receive tablets containing maltodextrin

Participants in both groups will take one tablet, three times a day, over an 8 week period.
Intervention code [1] 258005 0
Treatment: Other
Comparator / control treatment
Placebo (maltodextrin)
Control group
Placebo

Outcomes
Primary outcome [1] 262099 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS)will be used to assess activities of daily living, joint function and frequency of pain.
Timepoint [1] 262099 0
Participants will be required to complete the KOOS questionnaire, which takes about 5-10 minutes to complete, on days 1, 7, 14, 21, 28, 35, 42, 49 and 56 of the trial.
Primary outcome [2] 262100 0
The Visual Analogue Scale (VAS): A simple outcome measure that uses a line with "no pain" at one end and "pain at its very worst" at the other end. Participants will be required to mark a cross at the point they feel best represents their pain on that day.
Timepoint [2] 262100 0
Participants will complete the VAS on days 1, 7, 14, 21, 28, 35, 42, 49 and 56 of the trial.
Primary outcome [3] 262101 0
The participants will be required to keep a daily log of their medication usage, physical activity and any form of treatment they may receive. A treatment could be considered any visit to their local general practitioner, osteopath, physiotherapist, and any other form of manual therapy.
Timepoint [3] 262101 0
Daily entries from baseline for 8 weeks.
Secondary outcome [1] 273155 0
The Marx Activity Scale: The outcomes will reveal each patient's level of physical activity, an important factor that will be used later when analysing results.
Timepoint [1] 273155 0
Participants will be required to fill out this activity scale on day 1 of supplementation, prior to the consumption of the active ingredient or placebo
Secondary outcome [2] 273156 0
The Medical Outcomes Study 36-Item Short Form (SF-36) is a generic instrument that assesses eight health concepts and may detect unforeseen effects of the interventions used.
Timepoint [2] 273156 0
Participants will be required to complete the SF-36 on days 1, 28 and 56 of the trial.

Eligibility
Key inclusion criteria
- people experiencing regular, mild, undiagnosed knee pain
- knee pain must be experienced at least once a week
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- pregnancy
- breast feeding mothers
- previous diagnosis of a meniscal (knee cartilage) or ligamentous knee injury
- previous history of knee surgery,
-allergies to seafood, glucosamine, shark cartilage, chondroitin or Dimethyl sulphone
- allergies to maltodextrin wheat, corn, potatoes and other foods high in starch
- celiac disease
- participants who are currently taking containing glucosamine sulphate or have taken products containing glucosamine sulphate in the last 8 weeks
- cancer sufferers
- failure to provide written consent
- Diabetes Mellitus

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)
Potential participants who have expressed interest in participating in the study by contacting the principal investigator, will be screened over the phone by one of the student investigators and all communications will recorded. Potential participants will be asked a series of questions to assess eligibility for the study, those who meet the criteria will be invited to the initial meeting if they are still consenting.
The initial meeting with the participants will be held at the city campus of Victoria University. The entire process of the trial will be explained by the principal investigator. Participants will be asked to read information sheets regarding the trial and consent forms will have to be signed before participating in the trial.
Having satisfied the inclusion/exclusion criteria, and after signing an informed consent form, participants will be randomized into two equally sized groups, A or B, using a coin toss. Participants will be directed to take one of their allocated tablets, three times a day. Blinding of practitioners will be achieved by receiving the products in containers labeled either “A” or “B”. The researchers will be unaware of the contents of the containers. The supplier of the products will be advised not to announce the contents of the containers until the conclusion of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3611 0
3021
Recruitment postcode(s) [2] 3612 0
3011
Recruitment postcode(s) [3] 3613 0
3030
Recruitment postcode(s) [4] 3614 0
3000
Recruitment postcode(s) [5] 3615 0
3020
Recruitment postcode(s) [6] 3616 0
3015
Recruitment postcode(s) [7] 3617 0
3187
Recruitment postcode(s) [8] 3618 0
3195
Recruitment postcode(s) [9] 3619 0
3178
Recruitment postcode(s) [10] 3620 0
3802

Funding & Sponsors
Funding source category [1] 258467 0
University
Name [1] 258467 0
Victoria University
Country [1] 258467 0
Australia
Funding source category [2] 258468 0
Commercial sector/Industry
Name [2] 258468 0
Pharmafoods
Country [2] 258468 0
Australia
Primary sponsor type
Individual
Name
Dr Jim Kiatos
Address
School of Biomedical & Health Sciences
Faculty of Health Engineering & Science
Victoria University
P.O. Box 14428
Melbourne, Victoria 8001
Country
Australia
Secondary sponsor category [1] 257609 0
None
Name [1] 257609 0
Address [1] 257609 0
Country [1] 257609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260448 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 260448 0
Ethics Secretary,
Victoria University Human Research Ethics Committee
Office for Research
Victoria University PO Box 14428, Melbourne VIC 8001
Ethics committee country [1] 260448 0
Australia
Date submitted for ethics approval [1] 260448 0
16/02/2011
Approval date [1] 260448 0
13/05/2011
Ethics approval number [1] 260448 0
1/10/0216

Summary
Brief summary
Glucosamine sulphate is a supplement that is marketed as a joint builder. Potential benefits include: restoration in joint function, an increase in joint flexibility, and alleviation of joint pain. Previous investigations into glucosamine sulphate have found it to have a positive effect on cartilage regeneration within the knee joint, along with a lower incidence of adverse reactions when compared to other over the counter medications used to treat knee pain, such as non steroidal anti-inflammatory drugs.

This study will aim to determine whether oral supplementation with a product containing GS is effective in reducing pain and improving physical function of the knee joint in young people suffering from “regular (once a week), mild, undiagnosed knee pain”.
Male and female participants aged between 18-35 years of age will be recruited and randomly allocated into one of two groups:
1. Glucosamine sulphate containing product
2. Placebo (Maltodextrin, which is has no published effects on joint function)

The trial will last for 8 weeks, and a number of measures will be employed during this time to assess the effects of the glucosamine sulphate supplementation e.g. a daily log of medication usage and physical activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32193 0
Address 32193 0
Country 32193 0
Phone 32193 0
Fax 32193 0
Email 32193 0
Contact person for public queries
Name 15440 0
Dr Jim Kiatos
Address 15440 0
School of Biomedical and Health Sciences
Faculty of Health, Engineering & Science
Victoria University
P.O. Box 14428
Melbourne, Vic. 8001
Country 15440 0
Australia
Phone 15440 0
61 3 9919 1191
Fax 15440 0
Email 15440 0
[email protected]
Contact person for scientific queries
Name 6368 0
Dr Jim Kiatos
Address 6368 0
School of Biomedical and Health Sciences
Faculty of Health, Engineering & Science
Victoria University
P.O. Box 14428
Melbourne, Vic. 8001
Country 6368 0
Australia
Phone 6368 0
61 3 9919 1191
Fax 6368 0
Email 6368 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

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