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

Primary Purpose

Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hydrolyzed Collagen
Placebo
CalGo
Sponsored by
Hofseth Biocare ASA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring stiffness, pain, knee pain, hip pain, osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • Pregnancy or breastfeeding
  • Known fish allergy and history of hypersensitivity to any of the components in the interventional product.
  • Other reasons in which the principal investigator deems it necessary to exclude a potential participant.

Sites / Locations

  • Kristiansund Hospital
  • Hofseth Biocare ASA
  • Lovisenberg Diakonale Sykehus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Hydrolyzed Collagen type II

Maltodextrin

Unhydrolyzed Collagen type II (Salmon bone meal)

Arm Description

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.

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

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Mean change from from Baseline on the WOMAC pain subscale at Month 3 and Month 6.
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.
Change from Baseline on an 11-point likert Global Assessment Scale at Month 3 and Month 6.
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.
Change from Baseline in pain intensity on a Numerical Rating Scale at Month 3 and Month 6.
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".
Change from Baseline in number of rescue medications self-administered during the study period.
Rescue medications that participants may use on an as needed basis include Paracetamol, typical NSAIDs, and analgesics containing opioids.
Change from Baseline in self-assessed quality of life on the EQ-5D-3L instrument at Month 3 and Month 6.
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).
Difference in number of Adverse Events between the study groups.
Reported between the hydrolyzed collagen group and placebo group, and the CalGo group and placebo group.

Full Information

First Posted
September 23, 2021
Last Updated
September 25, 2023
Sponsor
Hofseth Biocare ASA
Collaborators
Møre og Romsdal Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05070871
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hofseth Biocare ASA
Collaborators
Møre og Romsdal Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
Keywords
stiffness, pain, knee pain, hip pain, osteoarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrolyzed Collagen type II
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
10 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once or twice daily dosing. Duration: 6 months.
Arm Title
Unhydrolyzed Collagen type II (Salmon bone meal)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolyzed Collagen
Intervention Description
Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Pure maltodextrin.
Intervention Type
Dietary Supplement
Intervention Name(s)
CalGo
Intervention Description
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 Outcome Measure Information:
Title
Mean change from Baseline in WOMAC composite score at Month 3 and Month 6.
Description
A change in osteoarthritis symptomatology is assessed using a disease specific questionnaire (WOMAC 3.1).
Time Frame
Baseline, 3 Months, and 6 Months
Secondary Outcome Measure Information:
Title
Mean change from from Baseline on the WOMAC pain subscale at Month 3 and Month 6.
Description
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.
Time Frame
Baseline, 3 Months, and 6 Months
Title
Change from Baseline on an 11-point likert Global Assessment Scale at Month 3 and Month 6.
Description
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.
Time Frame
Baseline, 3 Months, and 6 Months
Title
Change from Baseline in pain intensity on a Numerical Rating Scale at Month 3 and Month 6.
Description
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".
Time Frame
Baseline, 3 Months, and 6 Months
Title
Change from Baseline in number of rescue medications self-administered during the study period.
Description
Rescue medications that participants may use on an as needed basis include Paracetamol, typical NSAIDs, and analgesics containing opioids.
Time Frame
Baseline, 6 Months
Title
Change from Baseline in self-assessed quality of life on the EQ-5D-3L instrument at Month 3 and Month 6.
Description
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).
Time Frame
Baseline, 3 Months, and 6 Months
Title
Difference in number of Adverse Events between the study groups.
Description
Reported between the hydrolyzed collagen group and placebo group, and the CalGo group and placebo group.
Time Frame
3 Months, and 6 Months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Bjerkestrand Lian, MD, PhD
Organizational Affiliation
Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kristiansund Hospital
City
Kristiansund
State/Province
Møre Og Romsdal
ZIP/Postal Code
6508
Country
Norway
Facility Name
Hofseth Biocare ASA
City
Ålesund
State/Province
Møre Og Romsdal
ZIP/Postal Code
6005
Country
Norway
Facility Name
Lovisenberg Diakonale Sykehus
City
Oslo
ZIP/Postal Code
0456
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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