Undenatured Type II Collagen for Knee Osteoarthritis Pain
ConditionOsteoarthritis, Knee
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age31+
SponsorUniversidad Católica San Antonio de Murcia
About this trial
This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II, Nuvicol SII, or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 30 years.
Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified American College of Rheumatology criteria.
Persistent knee pain associated with osteoarthritis with a baseline VAS pain assessment score of at least 30 mm.
Subjects must not have narcotic or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
Disqualifiers
Serious or terminal illnesses.
Allergy or hypersensitivity to any component of the product under study.
Vegan or vegetarian diet.
Current use of glucosamine, chondroitin sulfate, collagen, hyaluronic infiltrations, or any supplement indicated for joint health.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Dietary supplementMatching placebo capsules containing maltodextrin and magnesium stearate, orally once daily for 4 months.
Nuvicol II
Dietary supplementUndenatured type II collagen from chicken source, 40 mg orally once daily for 4 months.
Nuvicol SII
Dietary supplementUndenatured type II collagen from salmon source, 40 mg orally once daily for 4 months.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Nuvicol IIExperimental treatment 1 intervention
Group B: Nuvicol SIIExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in joint pain intensity measured by visual analog scale
Joint pain intensity will be measured using a 10-cm visual analog scale. The participant marks pain intensity from 0, no pain, to 10, worst imaginable pain. The primary endpoint is change from baseline in VAS pain score.
Time frame
Baseline to 16 weeksSecondary outcomes
1
Change in knee-related quality of life measured by KOOS
KOOS evaluates pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0 to 100 scale, where 0 represents extreme knee problems and 100 represents no knee problems.
Time frame
Baseline to 16 weeks; also assessed at 30, 60, and 90 days2
Change in pain, stiffness, and physical function measured by WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index assesses pain, stiffness, and physical function in participants with knee osteoarthritis.
Time frame
Baseline to 16 weeks; also assessed at 30, 60, and 90 days3
Change in concomitant analgesic medication use
Daily prescribed and rescue analgesic medication use will be recorded to evaluate changes in the need for analgesic medication.
Time frame
Baseline to 16 weeks4
Change in knee muscle function by dynamometry
Isometric and isokinetic knee muscle function will be measured with a Biodex System 3 dynamometer in the painful knee, including extension and flexion assessments.
Time frame
Baseline, 8 weeks, and 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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