Clinical trial NCT05070871: A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
Official title: A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: stiffness
pain
knee pain
hip pain
osteoarthritis
Lead sponsor: Hofseth Biocare ASA
Sponsor class: INDUSTRY
Collaborators: name: Møre og Romsdal Hospital Trust
First posted: 2021-10-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis.

Detailed description: The current study is part of a larger project called the CalGo-project. The overall purpose of the study is to use bone meal from salmon to promote skeletal health. Specifically, the potential for hydrolyzed collagen type II derived from salmon bone meal in ameliorating pain, stiffness and function in participants diagnosed with osteoarthritis will be evaluated over a time period of 6 months. Past literature indicates that collagen derivatives may be a potential supportive strategy in people suffering from osteoarthritis. Osteoarthritis is a common but complex joint disease with significant unmet medical needs, as there are currently no disease-modifying drugs available. Osteoarthritis represents a global health burden and the only curative treatment when pain becomes unmanageable, is joint replacement.

The dimensions of pain, stiffness, and function will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1). Plain x-rays with Kellgren-Lawrence grading will be employed to classify the severity of osteoarthritis. 100 potential participants will be screened for eligibility. Participants who meet the eligibility criteria will be randomized in a double-blind manner to receive 10 capsules daily of hydrolyzed collagen type II (a total of 5000 mg), 10 capsules daily of salmon bone meal, or 10 capsules daily of placebo.

Eligibility criteria: Inclusion Criteria:

* Characteristic joint pain indicating osteoarthritis (OA) in the hip(s) or knee(s).
* A radiologically and clinically verified diagnosis of mild to moderate OA graded 1-3 on a Kellgren-Lawrence (KL) grading scale in affected hips or knees.
* Age 18-70 years.
* Familiar with the Norwegian language, both in writing and orally.
* Willingness to participate in the study.

Exclusion Criteria:

* A radiologically and clinically verified diagnosis of severe OA graded 4 on a KL grading scale in affected hips or knees.
* Use of drugs (and supplements) known to influence bone and joint metabolism, including Glucocorticoids, \> 500 mg daily intake of elemental calcium in medication or supplement form, \> 800 IU daily intake of vitamin D3, cancer therapy
* Pregnancy or breastfeeding
* Known fish allergy and history of hypersensitivity to any of the components in the interventional product.
* Other reasons which the principal investigator deems it necessary to exclude a potential participant.

Primary outcomes:
measure: Mean change from Baseline in WOMAC composite score at Month 3 and Month 6.
timeFrame: Baseline, 3 Months, and 6 Months
Secondary outcomes:
measure: Mean change from from Baseline on the WOMAC pain subscale at Month 3 and Month 6.
timeFrame: Baseline, 3 Months, and 6 Months
measure: Change from Baseline on an 11-point likert Global Assessment Scale at Month 3 and Month 6.
timeFrame: Baseline, 3 Months, and 6 Months
measure: Change from Baseline in pain intensity on a Numerical Rating Scale at Month 3 and Month 6.
timeFrame: Baseline, 3 Months, and 6 Months
measure: Change from Baseline in number of rescue medications self-administered during the study period.
timeFrame: Baseline, 6 Months
measure: Change from Baseline in self-assessed quality of life on the EQ-5D-3L instrument at Month 3 and Month 6.
timeFrame: Baseline, 3 Months, and 6 Months
measure: Difference in number of Adverse Events between the study groups.
timeFrame: 3 Months, and 6 Months.
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Hospital
state: Møre Og Romsdal
city: Ålesund
country: Norway
facility: Hofseth Biocare ASA
state: Møre Og Romsdal
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Sykehus
Study officials:
affiliation: Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
name: Øystein Bjerkestrand Lian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: