A Single Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Clinical Trial to Evaluate the Sensitivity of Magnetic Resonance Imaging to Detect Change in Cartilage Structure and Composition in 30 Participants Diagnosed With Osteoarthritis of the Knee and Treated With Collagen Hydrolysate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- GELITA
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
研究概览
简要总结
This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.
详细描述
This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 49 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 49 years
- •chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
- •WOMAC pain subscale score ≥ 1
- •tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
- •clinical examination confirming knee pain or discomfort referable to the knee joint
- •prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
- •stable medication and/or supplement use
排除标准
- •use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
- •serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
- •individuals who are expected not to comply with the study protocol
- •plan to permanently relocate from the region during the trial period
- •planned knee arthroplasty in the study knee
- •active pathology of confounding origin which may cause pain, extending to the knee
- •pregnancy
- •any contra-indication to having an MRI scan
结局指标
主要结局
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
时间窗: 48 Weeks
次要结局
- To measure knee cartilage volume over 48 weeks at three time points.(48 Weeks)
- To measure and evaluate WOMAC pain subscale scores over 48 weeks.(48 Weeks)
- To evaluate change in physical function tests over 48 weeks.(48 Weeks)