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Efficacy of Non-animal Chondroitin Sulphate for Overweight Subjects With Knee Ostoarthritis.

NCT03731793 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-11-06

No results posted yet for this study

Summary

Knee osteoarthritis (OA) is predicted to become the fourth leading cause of disability worldwide by 2020. and is estimated to affect more than 40 million people in Europe and 4 million people in Italy. OA has multifactorial etiology and obesity is one of the most important risk factor for knee Regarding therapy of OA in 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a treatment algorithm for the management of knee OA. In Step 1 of the treatment, it is recommended to initiate therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Among SYSADOAs, the evidence is greatest for the effect of chondroitin sulfate (CS).

Sixty overweight subjects with knee osteoarthritis (OA) were recruited and randomly allocated to a group of treatment with 600 mg/d of non-animal Chondroitin sulphate (CS) or to a placebo group.

These measurements were considered:

Tegner Lysholm Knee Scoring (TLKS), Western Ontario and McMaster Universities Arthritis (WOMAC) index and Visual Analogue Scale (VAS) for pain were analyzed at time 0 and at 4 and 12 weeks. Health-related quality of life by ShortForm36, inflammation by C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were also evaluated, together with a body composition assessment performed by DXA.

Conditions

Interventions

BIOLOGICAL

Non-Animal Chondroitin Sulphate

Mythocondro® is an ichthyic-like chondroitin sulfate produced by chemical sulfation of a non-sulfated chondroitin backbone obtained by thermo-acid hydrolysis of the capsular polysaccharide naturally produced by an Escherichia coli strain.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Gnosis SpA

    collaborator UNKNOWN

  • Azienda di Servizi alla Persona di Pavia

    lead OTHER

Principal Investigators

  • Mariangela Rondanelli, Professor · IRCCS Mondino Foundation, Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-06-30
Completion
2018-10-20

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731793 on ClinicalTrials.gov