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

Azienda di Servizi alla Persona di Pavia

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Biological: Non-Animal Chondroitin Sulphate; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03731793

8810/02112017

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo. For 90 days one capsule/day.

Treatment:

Other: Placebo

Intervention Group

Experimental group

Description:

600 mg/day of non-animal Chondroitin Sulphate. One capsule/day for 90 days.

Treatment:

Biological: Non-Animal Chondroitin Sulphate