A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women

NCT05070871 | Completed

• 1 other identifier: CALGO-ART
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

stiffness; pain; knee pain; hip pain; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline in WOMAC composite score at Month 3 and Month 6.

  A change in osteoarthritis symptomatology is assessed using a disease specific questionnaire (WOMAC 3.1).

  Baseline, 3 Months, and 6 Months

Secondary Outcomes (6)

• Mean change from from Baseline on the WOMAC pain subscale at Month 3 and Month 6.

  Baseline, 3 Months, and 6 Months

• Change from Baseline on an 11-point likert Global Assessment Scale at Month 3 and Month 6.

  Baseline, 3 Months, and 6 Months

• Change from Baseline in pain intensity on a Numerical Rating Scale at Month 3 and Month 6.

  Baseline, 3 Months, and 6 Months

• Change from Baseline in number of rescue medications self-administered during the study period.

  Baseline, 6 Months

• Change from Baseline in self-assessed quality of life on the EQ-5D-3L instrument at Month 3 and Month 6.

  Baseline, 3 Months, and 6 Months

Study Arms (3)

Hydrolyzed Collagen type II

ACTIVE COMPARATOR

10 capsules daily of hydrolyzed collagen (CH) type II is taken per orally. Each capsule contains \~500 mg of CH. Once or twice daily dosing. Duration: 6 months.

Dietary Supplement: Hydrolyzed Collagen

Maltodextrin

PLACEBO COMPARATOR

10 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once or twice daily dosing. Duration: 6 months.

Other: Placebo

Unhydrolyzed Collagen type II (Salmon bone meal)

EXPERIMENTAL

10 capsules daily of salmon bone meal enriched with vitamin D3 is taken per orally. Each capsule contains 300 mg of maltodextrin, 200 mg of salmon bone meal (10 capsules = 2000 mg salmon bone meal = 340 mg elemental calcium in the form of microcrystalline hydroxyapatite), and 4 micrograms of vitamin D3 (10 capsules = 40 micrograms of vitamin D3 = 1600 IU).

Dietary Supplement: CalGo

Interventions

Hydrolyzed Collagen DIETARY_SUPPLEMENT

Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.

Hydrolyzed Collagen type II

Placebo OTHER

Pure maltodextrin.

Maltodextrin

CalGo DIETARY_SUPPLEMENT

CalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and collagen type 2.

Unhydrolyzed Collagen type II (Salmon bone meal)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead
• Møre og Romsdal Hospital Trust: collaborator

Study Sites (3)

Hofseth Biocare ASA

Ålesund, Møre og Romsdal, 6005, Norway

Location

Kristiansund Hospital

Kristiansund, Møre og Romsdal, 6508, Norway

Location

Lovisenberg Diakonale Sykehus

Oslo, 0456, Norway

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Øystein Bjerkestrand Lian, MD, PhD

  Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 7, 2021
• Study Start: September 22, 2021
• Primary Completion: December 27, 2023
• Study Completion: January 15, 2024
• Last Updated: February 13, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)