A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
Key facts
- Who runs it
- Hofseth Biocare ASA
- Where
- Norway3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 98 people enrolled
- Started
- 22 Sept 2021
- Ended
- 15 Jan 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Hydrolyzed Collagen
- Placebo
- CalGo
- Record updated
- 13 February 2024
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- Known fish allergy and history of hypersensitivity to any of the components in the interventional product
- 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
- A radiologically and clinically verified diagnosis of severe OA graded 4 on a KL grading scale in affected hips or knees
- Pregnancy or breastfeeding
- Other reasons which the principal investigator deems it necessary to exclude a potential participant
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis.
The 3 groups in the trial
- Hydrolyzed Collagen type IIExisting treatment, for comparison
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.
Treatment: Hydrolyzed Collagen
- MaltodextrinPlacebo, for comparison
10 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once or twice daily dosing. Duration: 6 months.
Treatment: Placebo
- Unhydrolyzed Collagen type II (Salmon bone meal)Treatment being tested
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).
Treatment: CalGo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
- Record updated
- 13 February 2024