OsteoarthritisNCT00086229
Absorption and Distribution of Glucosamine and Chondroitin
A study testing Glucosamine and Chondroitin in people with Osteoarthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to examine the way the dietary supplements glucosamine and chondroitin are absorbed and distributed throughout the body. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Glucosamine and Chondroitin
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to walk
Who cannot join
- Allergy to glucosamine, chondroitin, or shellfish
- Liver or kidney disease
- Diabetes mellitus
- Concurrent use of other complementary or alternative therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
Official title: A Pharmacokinetic Study of Glucosamine and Chondroitin
The purpose of this study is to examine the way the dietary supplements glucosamine and chondroitin are absorbed and distributed throughout the body.
Read the detailed description
Osteoarthritis is the most common musculoskeletal disease in the world. While predisposing conditions have been identified, the actual cause of osteoarthritis remains unknown. Traditional treatments, most often anti-inflammatory drugs and pain relievers, produce variable results and may cause significant toxicity. The use of complementary and alternative therapies in the treatment of osteoarthritis has become more common, and particular interest has focused on glucosamine and chondroitin treatments. This study will examine the pharmacokinetics of glucosamine and chondroitin.
This study consists of two phases. In Phase I, participants will have two study visits, during which multiple blood samples will be taken to determine levels of glucosamine and chondroitin found naturally in the body. During Phase II, participants will be randomly assigned to receive glucosamine, chondroitin, or a combination of the two for 3 months. Blood samples will be taken at each of the three Phase II study visits to examine the pharmacokinetics of glucosamaine and chondroitin.
- Conditions
- Osteoarthritis
- Being tested
- Glucosamine, Chondroitin
- Keywords
- Complementary Therapies
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucosamineDrug
ChondroitinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2004 (estimated)
- Study startApr 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Christopher G. Jackson, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086229
- Sponsor's protocol ID
- R21AT001938-01
- Status last verified
- Aug 2006
- First submitted
- 28 Jun 2004
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Glucosamine and Chondroitin
- ClinicalTrials.gov ID
- NCT00086229
- Acronym / sponsor ID
- R21AT001938-01
- Conditions
- Osteoarthritis
- Keywords
- Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Apr 2004
- Study completion
- Jan 2006
- First posted
- 29 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the way the dietary supplements glucosamine and chondroitin are absorbed and distributed throughout the body.
Detailed description
Osteoarthritis is the most common musculoskeletal disease in the world. While predisposing conditions have been identified, the actual cause of osteoarthritis remains unknown. Traditional treatments, most often anti-inflammatory drugs and pain relievers, produce variable results and may cause significant toxicity. The use of complementary and alternative therapies in the treatment of osteoarthritis has become more common, and particular interest has focused on glucosamine and chondroitin treatments. This study will examine the pharmacokinetics of glucosamine and chondroitin.
This study consists of two phases. In Phase I, participants will have two study visits, during which multiple blood samples will be taken to determine levels of glucosamine and chondroitin found naturally in the body. During Phase II, participants will be randomly assigned to receive glucosamine, chondroitin, or a combination of the two for 3 months. Blood samples will be taken at each of the three Phase II study visits to examine the pharmacokinetics of glucosamaine and chondroitin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to walk
Key exclusion criteria (4 listed)
- Allergy to glucosamine, chondroitin, or shellfish
- Liver or kidney disease
- Diabetes mellitus
- Concurrent use of other complementary or alternative therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine | Drug | – |
| Chondroitin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher G. Jackson, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucosamine and Chondroitin in people with Osteoarthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.