Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Plasma uncarboxylated matrix gla protein
研究概览
简要总结
The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.
As of February 2025, based on attrition rate below what was initially expected, we revised our planned enrollment from 50 to 35, to achieve the original goal of 30 completers. This was approved by the study sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Male or post-menopausal female (no menses in the last year)
- •Plasma phylloquinone <1.0 nmol/L
- •Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had pain, aching, or stiffness in or around your knee(s) on most days for at least one month?"
- •Kellgren-Lawrence (KL) grade 2-3 in at least one knee
- •Ability to understand study procedures and to comply with them for the entire length of the study
- •Ability to answer questions by phone
- •Ability to swallow capsules
排除标准
- •KL grade 4 in at least one knee
- •Inability to walk
- •Cognitive impairment (based on a Montreal Cognitive Assessment Test score ≤ 17)
- •Widespread pain
- •Malabsorption disorders (e.g. advance liver disease, stage 4 or 5 chronic renal disease, Crohn's disease, celiac sprue)
- •Serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation
- •Plan to permanently relocate from the greater Boston, MA or Chapel Hill NC areas during the trial period
- •Planned knee or hip arthroplasty during the study period
- •Undergoing cancer treatment
- •< 50 years old
- •Circulating phylloquinone ≥ 1.0 nmol/L
- •Warfarin (Jantoven) use
- •Use of other investigational drugs
- •Use of herbal, botanical or vitamin K supplements
- •Use of assistive walking devices
结局指标
主要结局
Plasma uncarboxylated matrix gla protein
时间窗: 24 weeks
Plasma uncarboxylated matrix gla protein is considered a functional indicator of vitamin K status. We will evaluate how it changes in response to 1 mg/d vitamin K supplementation in adults with low vitamin K status at baseline and with radiographic knee OA.
次要结局
- Plasma phylloquinone(24 weeks)
研究者
Sarah Booth
Senior Scientist and Center Director
Tufts University