A Randomized, Double-blind Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Mean change from Baseline in WOMAC composite score at Month 3 and Month 6.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of hydrolyzed collagen in osteoarthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean change from Baseline in WOMAC composite score at Month 3 and Month 6.
时间窗: Baseline, 3 Months, and 6 Months
A change in osteoarthritis symptomatology is assessed using a disease specific questionnaire (WOMAC 3.1).
次要结局
- 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 on an 11-point likert Global Assessment Scale at Month 3 and Month 6.(Baseline, 3 Months, and 6 Months)
- 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 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)
- Difference in number of Adverse Events between the study groups.(3 Months, and 6 Months.)