The Role of Vitamin K on Knee Osteoarthritis Outcomes
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in uncarboxylated matrix Gla protein (ucMGP) levels
研究概览
简要总结
The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,
The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation.
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
- •Men ≥50 years old
- •Women ≥60 years old
- •Clinical diagnosis of knee OA by the treating rheumatologist
- •English fluency
排除标准
- •Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)
研究组 & 干预措施
Placebo
Participants randomized to this arm will take 1 placebo pill daily for 4 weeks.
干预措施: Placebo (Other)
Vitamin K1 1000 µg
Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks.
干预措施: K1 1000 µg (Drug)
Vitamin K1 500 µg
Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks.
干预措施: Vitamin K1 500 µg (Drug)
Vitamin K2 (MK-7) 300 µg
Participants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks.
干预措施: Vitamin K2 (MK-7) 300 µg (Drug)
结局指标
主要结局
Change in uncarboxylated matrix Gla protein (ucMGP) levels
时间窗: Baseline, 4 weeks
Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).
Change in phylloquinone levels
时间窗: Baseline, 4 weeks
Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).
Sufficient phylloquinone levels
时间窗: Baseline, 4 weeks
Defined as the the proportion of participants achieving phylloquinone level of \>1.0 nmol/L, which is the level achieved when adequate intakes are met.
Change in menaquinone-7 (MK-7) levels
时间窗: Baseline, 4 weeks
Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.
次要结局
- Study adherence(4 weeks)
- Participant acceptability of intervention(4 weeks)