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

NCT03731793 | Completed Phase 4

• 1 other identifier: 8810/02112017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

non-animal chondroitin sulphate; knee osteoarthritis; overweight

Outcome Measures

Primary Outcomes (3)

• Change in Generic Pain (VAS)

  Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain. A VAS reduction is expected only in treatment group.

  0, 30, 90 days

• Change in Knee Pain (WOMAC)

  Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations. A significant decrease in expected in treatment group.

  0, 30, 90 days

• Change in Knee Functionality (TLKS)

  Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability. An increase in expected in treatment group.

  0, 30, 90 days

Secondary Outcomes (3)

• Change in Quality of Life (SF-36)

  0, 30, 90 days

• Change in Inflammatory Markers circulating levels (CRP, ESR)

  0, 30, 90 days

• Change in total Fat Mass, Total Free Fat Mass and Visceral adipose tissue (DXA)

  0, 30, 90 days

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Placebo. For 90 days one capsule/day.

Other: Placebo

Intervention Group

EXPERIMENTAL

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

Biological: Non-Animal Chondroitin Sulphate

Interventions

Non-Animal Chondroitin Sulphate BIOLOGICAL

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.

Intervention Group

Placebo OTHER

Placebo

Placebo Group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead
• Gnosis SpA: collaborator

Study Sites (1)

Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Overweight

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariangela Rondanelli, Professor

  IRCCS Mondino Foundation, Pavia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Full randomization and full blind study. Intervention was named by "integratore A" and "integratore B"
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Model Details: Double-blind randomized placebo controlled study. 90 days of treatment with 600 mg/d of non-animal Chondroitin Sulphate or placebo

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: October 20, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)