Clinical trial NCT03731793: Efficacy of Non-animal Chondroitin Sulphate for Overweight Subjects With Knee Ostoarthritis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: non-animal chondroitin sulphate
knee osteoarthritis
overweight
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
Collaborators: name: Gnosis SpA
First posted: 2018-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized placebo controlled study. 90 days of treatment with 600 mg/d of non-animal Chondroitin Sulphate or placebo
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Caucasian subjects, males and females, with the following characteristics were included in the trial and randomly assigned to the experimental group (N=30) or a control group (N=30): Individuals overweight (BMI \> 25 kg/m2), aged 40-74.; Mobility impairment, joint discomfort or established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA).

Exclusion Criteria:

* Anyone with evidence of heart disease, kidney or liver disease, or any other disease that might influence the results of the study was excluded.

Primary outcomes:
measure: Change in Generic Pain (VAS)
timeFrame: 0, 30, 90 days
measure: Change in Knee Pain (WOMAC)
timeFrame: 0, 30, 90 days
measure: Change in Knee Functionality (TLKS)
timeFrame: 0, 30, 90 days
Secondary outcomes:
measure: Change in Quality of Life (SF-36)
timeFrame: 0, 30, 90 days
measure: Change in Inflammatory Markers circulating levels (CRP, ESR)
timeFrame: 0, 30, 90 days
measure: Change in total Fat Mass, Total Free Fat Mass and Visceral adipose tissue (DXA)
timeFrame: 0, 30, 90 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Study officials:
affiliation: IRCCS Mondino Foundation, Pavia
name: Mariangela Rondanelli, Professor
role: STUDY_DIRECTOR
References: