NCT03731793

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

Efficacy and Safety of Non-animal Chondroitin Sulphate Supplementation in the Treatment of Moderate Knee Osteoarthritis in a Group of Overweight Subjects: a Randomized, Double Blind, Placebo-controlled Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Azienda di Servizi alla Persona di Pavia · Academic / Other
• Sex: All
• Age: 40 Years – 74 Years
• Healthy volunteers: Not accepted

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

• Knee Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-06-30
• Completion: 2018-10-20
• First posted: 2018-11-06
• Last updated: 2018-11-06

Locations

1 site across 1 country: Italy