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Tracking Information | |||||
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First Received Date ICMJE | June 28, 2004 | ||||
Last Updated Date | August 16, 2006 | ||||
Start Date ICMJE | April 2004 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00086229 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Absorption and Distribution of Glucosamine and Chondroitin | ||||
Official Title ICMJE | A Pharmacokinetic Study of Glucosamine and Chondroitin | ||||
Brief Summary | The purpose of this study is to examine the way the dietary supplements glucosamine and chondroitin are absorbed and distributed throughout the body. |
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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. |
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Study Phase | |||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study | ||||
Condition ICMJE | Osteoarthritis | ||||
Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 70 | ||||
Completion Date | January 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00086229 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | R21 AT001938-01 | ||||
Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
Verification Date | August 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |