Novel Health Effects of Vitamin K: a Placebo-controlled Randomized Trial in the General Population (InterVitaminK)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Total coronary artery calcification
研究概览
简要总结
The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.
详细描述
Background: Research suggest that vitamin K may have protective effects against non-communicable and age-related diseases as diverse as cardiovascular disease (CVD), osteoporosis, and type 2 diabetes (T2D). However, there is a need for larger studies investigating the potential health effects of vitamin K in the general population.
Objective: The objective of the InterVitaminK trial is to investigate the effects of vitamin K (menaquinone-7, MK-7) supplementation on cardiovascular, metabolic, and bone health.
Hypothesis: The primary hypothesis is that vitamin K supplementation will reduce the progression of coronary artery calcification (CAC) with 15% compared with placebo.
Methods: The InterVitaminK trial is a double-blinded, placebo-controlled, randomized intervention trial. The trial will be conducted in Denmark at the Center for Clinical Research and Prevention and the CT scans will be performed at Rigshospitalet, Denmark. Participants from the Inter99 cohort with detectable CAC (Agatson score >=10) are eligible for the trial. Participants will be randomized 1:1 to receive one daily tablet with MK-7 or placebo for a period of 3 years. Randomization is done in blocks of 6 using computer generated random numbers. Participants are invited for a health examination at baseline and after 1, 2, and 3 years intervention. CT scans are performed at baseline and at 3-year follow-up.
Outcomes: The primary study outcome is progression of CAC from baseline to 3-year follow-up, assessed by Cardiac CT scans. Secondary outcomes are bone mineral density, pulmonary function, and biomarkers of insulin resistance.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, data collectors, and investigators are blinded of the allocation throughout the study period. The randomization list is generated and kept by a statistician employed at the Center for Clinical Research and Prevention, but not involved in the trial. Kappa Bioscience AS, Oslo, Norway, keeps the randomization list for labelling of investigational products. The randomization list will be made available to one DSMB member if safety concerns arise during the study period.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Detectable CAC (Agatson score >=10) assessed by Cardiac Computed Tomography (CT) scan in the Inter99 20-year follow-up study
排除标准
- •Manifest CVD (prior cerebral infarct, prior myocardial infarct, prior percutaneous coronary intervention or prior coronary artery bypass surgery)
- •Noise on the CT scan, which complicates an accurate assessment of CAC and interpretation of the CT scan. An example is a pacemaker
- •Current treatment with Vitamin K antagonist (VKA).
- •History of coagulation disorders (hemophilia, von Willebrand disease, sickle cell anemia)
- •Active malignant disease (ongoing treatment)
- •Previous surgical removal of the thyroid gland, or one or more of the parathyroid glands
- •Regular use of vitamin K supplements other than trial tablets
- •Pregnancy or breastfeeding
研究组 & 干预措施
Intervention
Intervention treatment . Dietary supplementation with Menaquinone-7 (MK-7) tablet (333 µg/day). MK-7 (K2VITAL®DELTA) tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.
干预措施: Menaquinone-7 (MK-7) tablet (333 µg) (Dietary Supplement)
Placebo
Placebo tablet (no active treatment). The placebo tablets will match the intervention treatment in both taste and appearance. Placebo tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.
干预措施: Placebo tablet (Dietary Supplement)
结局指标
主要结局
Total coronary artery calcification
时间窗: Baseline to three years of follow-up
Total coronary artery calcification score (unit: Agatston score) in the coronary arteries, assessed by non-contrast Cardiac CT scans. A high score reflects higher degree of calcification in the coronary arteries and increased risk of coronary artery disease. The outcome will be evaluated by randomization group (active versus placebo).
次要结局
- Arterial stiffness(Baseline to three years of follow-up)
- Aortic valve calcifications(Baseline to three years of follow-up)
- Coronary plaque composition(Baseline to three years of follow-up)
- Blood pressure(Baseline to three years of follow-up)
- Bone mineral density(Baseline to three years of follow-up)
- Pulmonary function(Baseline to three years of follow-up)
- Insulin resistance(Baseline to three years of follow-up)
研究者
Allan Linneberg
Director, Professor, MD, PhD
Bispebjerg Hospital