Individual Differences in Glucosamine Sulfate Exposure Levels

NCT ID: NCT03201276

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-02

Study Completion Date

2019-10-01

Brief Summary

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Glucosamine is an important part of the treatment strategy for osteoarthritis, but its effectiveness is still controversial. To explain the efficacy differences of glucosamine, in this study the investigators detect the concentration of glucosamine in the plasma and synovial fluid, some effect indexes such as inflammatory markers and gene polymorphism of glucosamine transporters. On the one hand, the investigators compare the plasma peak and gluten glucosamine concentration and the concentration in synovial fluid among participants to observe the individual differences of glucosamine exposure in vivo. On the other hand, the investigators investigate the correlation between drug concentrations, effect index and gene polymorphism. The hypothesis is that glucosamine exposure in vivo has individual differences and gene polymorphism can explain this differences.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Drug group

patients taking glucosamine

Glucosamine Sulfate

Intervention Type DRUG

Patients taking glucosamine sulfate 1500mg every day for at least four days.

Interventions

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Glucosamine Sulfate

Patients taking glucosamine sulfate 1500mg every day for at least four days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. patients undergoing total knee arthroplasty for knee osteoarthritis;
2. 60-80 years.

Exclusion Criteria

1. patients with severe liver or renal insufficiency;
2. patients allergic to glucosamine or any excipients in tablets;
3. patients who have been treated with glucosamine within three months;
4. patients who are unable to cooperate with the study;
5. continuous medication is less than 4 days;
6. patients with diarrhea, vomiting and other adverse reactions during medication.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Qing Jiang

Vice Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Qing Jiang

Role: CONTACT

+8613605192953

Ruijuan Xu

Role: CONTACT

+8613851502360

References

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Chan PS, Caron JP, Orth MW. Effects of glucosamine and chondroitin sulfate on bovine cartilage explants under long-term culture conditions. Am J Vet Res. 2007 Jul;68(7):709-15. doi: 10.2460/ajvr.68.7.709.

Reference Type BACKGROUND
PMID: 17605605 (View on PubMed)

Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, Blanco FJ, Benito P, Martin-Mola E, Paulino J, Marenco JL, Porto A, Laffon A, Araujo D, Figueroa M, Branco J. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis Rheum. 2007 Feb;56(2):555-67. doi: 10.1002/art.22371.

Reference Type BACKGROUND
PMID: 17265490 (View on PubMed)

Setnikar I, Rovati LC. Absorption, distribution, metabolism and excretion of glucosamine sulfate. A review. Arzneimittelforschung. 2001 Sep;51(9):699-725. doi: 10.1055/s-0031-1300105.

Reference Type BACKGROUND
PMID: 11642003 (View on PubMed)

Other Identifiers

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glucosaminexzh

Identifier Type: -

Identifier Source: org_study_id

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