Skip to main content
OpenTrials
Completed

NCT Number: NCT05070871

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristiansund Hospital, Kristiansund, Møre og Romsdal, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrolyzed collagen

Dietary Supplement

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

Placebo

Other

Pure 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.

Primary outcomes

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

    Time frame: Baseline, 3 Months, and 6 Months

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

Secondary outcomes

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

    Time frame: Baseline, 3 Months, and 6 Months

    Pain is evaluated using the pain dimension of WOMAC 3.1, a disease-specific questionnaire. The pain subscale includes 5 items that assesses pain intensity. A score is produced when the value of each item is summarized. A higher score indicates worse pain.

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

    Time frame: Baseline, 3 Months, and 6 Months

    A GAS scale gives an overall picture of an individuals' self-assessed effect of treatment. The individual is asked to compare the present health status with their health status at a previous point in time. The magnitude of this difference is scored numerically. In this study, we will use GAS on a 11-point Likert rating scale ranging from "completely recovered" to "worse than ever", with 0 being "unchanged" status.

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

    Time frame: Baseline, 3 Months, and 6 Months

    In this study, we will employ an 11-point (i.e., 0 to 10) Numerical Rating Scale as was recommended for use in chronic pain trials according to 2005 IMMPACT guidelines. 0 represents "No pain", and 10 represents "The most intense pain imaginable".

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

    Time frame: Baseline, 6 Months

    Rescue medications that participants may use on an as needed basis include Paracetamol, typical NSAIDs, and analgesics containing opioids.

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

    Time frame: Baseline, 3 Months, and 6 Months

    EQ-5D-3L is a standardized instrument used to measure generic quality of life based on five distinct dimensions. EQ-5D-3L contains two parts. The first part contains five questions that the individual must answer and includes mobility (walking), self-care, usual activities, pain/discomfort, and anxiety/depression. For each item, there are three possible answers. Results are reported as a five-digit number ranging from 11111 (best health status) to 33333 (worst health status).

  6. Difference in number of Adverse Events between the study groups.

    Time frame: 3 Months, and 6 Months.

    Reported between the hydrolyzed collagen group and placebo group, and the CalGo group and placebo group.

Sponsors and collaborators

Lead sponsor

Hofseth Biocare ASA

Industry

Collaborators

  • Møre og Romsdal Hospital Trust

Registry information

Official study title

A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 7, 2021
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.