OsteoarthritisNCT05070871
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
A study testing Hydrolyzed Collagen and CalGo in people with Osteoarthritis and Osteoarthritis, Knee, run by Hofseth Biocare ASA at 3 sites in Norway.
Trial summary
The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Hydrolyzed Collagen and CalGo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 3 sitesNorway
- Study dates
- 22 Sep 2021to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Hofseth Biocare ASA
Ålesund, Møre og Romsdal, 6005
Kristiansund Hospital
Kristiansund, Møre og Romsdal, 6508
Lovisenberg Diakonale Sykehus
Oslo, 0456
About this study
Official title: A Randomized, Double-blind 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.
Read the 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.
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Hydrolyzed Collagen, Placebo, CalGo
- Keywords
- stiffness, pain, knee pain, hip pain, osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed CollagenDietary supplement
Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.
PlaceboOther
Pure maltodextrin.
CalGoDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Dietary Supplement: CalGo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: Baseline, 3 Months, and 6 Months
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.
Measured: Baseline, 3 Months, and 6 Months
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".
Measured: Baseline, 3 Months, and 6 Months
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.
Measured: Baseline, 6 Months
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).
Measured: Baseline, 3 Months, and 6 Months
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.
Measured: 3 Months, and 6 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start22 Sep 2021
- Primary completion27 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Møre og Romsdal Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Øystein Bjerkestrand Lian, MD, PhD, Principal investigator, Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070871
- Sponsor's protocol ID
- CALGO-ART
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
- ClinicalTrials.gov ID
- NCT05070871
- Acronym / sponsor ID
- CALGO-ART
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- stiffness, pain, knee pain, hip pain, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Collaborators
- Møre og Romsdal Hospital Trust
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed Collagen type II | Active comparator | Dietary Supplement: Hydrolyzed Collagen10 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. |
| Maltodextrin | Placebo comparator | Other: Placebo10 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once or twice daily dosing. Duration: 6 months. |
| Unhydrolyzed Collagen type II (Salmon bone meal) | Experimental | Dietary Supplement: CalGo10 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed CollagenHydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon. | Dietary supplement | Hydrolyzed Collagen type II |
| PlaceboPure maltodextrin. | Other | Maltodextrin |
| CalGoCalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and collagen type 2. | Dietary supplement | Unhydrolyzed Collagen type II (Salmon bone meal) |
Primary outcome
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).
6 secondary outcomes
Mean change from from Baseline on the WOMAC pain subscale at Month 3 and Month 6.
Time frame: Baseline, 3 Months, and 6 Months
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
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
Change from Baseline in number of rescue medications self-administered during the study period.
Time frame: Baseline, 6 Months
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
Difference in number of Adverse Events between the study groups.
Time frame: 3 Months, and 6 Months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Bjerkestrand Lian, MD, PhD principal investigator
Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed Collagen and CalGo in people with Osteoarthritis and Osteoarthritis, Knee, run by Hofseth Biocare ASA at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline in WOMAC composite score at Month 3 and Month 6. (time frame: Baseline, 3 Months, and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.