Vitamin K for Heart Disease

(Nutricog Trial)

Overseen By Bouchra Ouliass, B.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montreal Heart Institute

Must not be taking: Warfarin

Disqualifiers: Recent coronary syndrome, Heart failure, Depression, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this pilot study is to obtain a preliminary assessment of the effect of VK supplementation on cognitive performance and vascular function in adults with stable Coronary Heart Disease (CHD)

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have recently changed your medication in the last two weeks or if you are using Warfarin (a blood thinner).

Is Vitamin K safe for human use?

Vitamin K is generally safe for human use, with no proven toxicity for its natural forms. However, it is important to note that excessive intake may interfere with medications like warfarin, which are used to prevent blood clots. ^{1 2 3 4 5}

How does Vitamin K treatment differ from other heart disease treatments?

Vitamin K is unique for heart disease treatment because it may help prevent calcium buildup in arteries, which is linked to atherosclerosis (hardening of the arteries). Unlike other treatments, Vitamin K is a fat-soluble vitamin that supports blood clotting and bone health, potentially offering a novel approach to cardiovascular health by addressing vitamin deficiencies that contribute to heart disease. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Vitamin K for heart disease?

Research suggests that vitamin K may help reduce the risk of heart disease by managing cardiometabolic risk factors and preventing vascular calcification, which is linked to advanced atherosclerosis (hardening of the arteries). Additionally, higher intake of vitamin K1 is associated with a lower risk of death from heart disease. ^{1 9 10 11 12}

Who Is on the Research Team?

Guylaine Ferland, PhD

Principal Investigator

Université de Montréal

Are You a Good Fit for This Trial?

This trial is for adults with stable Coronary Heart Disease (CHD) who are interested in exploring the potential cognitive and vascular benefits of Vitamin K supplementation.

Inclusion Criteria

I do not take vitamin K supplements or cognitive aids.

I am 60 years old or older.

My heart disease condition is stable.

Exclusion Criteria

I have a condition that affects how my body absorbs nutrients.

I have not had a recent heart attack or heart surgery in the last 3 months.

Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 0.5 mg/day phylloquinone or placebo for 12 weeks

12 weeks

Baseline and post-intervention visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin K

Trial Overview The NutriCog study is testing whether taking Vitamin K supplements can improve brain function and blood vessel health in people with CHD, compared to a placebo (a substance with no active drug).

How Is the Trial Designed?

Group I: Dietary Supplement: Vitamin K Experimental Treatment 1 Intervention

Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Group II: Dietary Supplement: Placebo Placebo Group 1 Intervention

Participants receive daily placebo for 12 weeks

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials

125

Recruited

85,400+

Citations

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Effect of Vitamin K Supplementation on Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Quantifying dietary vitamin K and its link to cardiovascular health: a narrative review. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Association of vitamin K with cardiovascular events and all-cause mortality: a systematic review and meta-analysis. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Association between vitamin K1 intake and mortality in the Danish Diet, Cancer, and Health cohort. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Anticoagulation control with daily low-dose vitamin k to reduce clinically adverse outcomes and international normalized ratio variability: a systematic review and meta-analysis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The Role of Vitamin K Status in Cardiovascular Health: Evidence from Observational and Clinical Studies. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Vitamin K in parenteral nutrition. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Educational and information needs of patients under vitamin K antagonist therapy]. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Vitamin K metabolism: current knowledge and future research. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Death Before Age 65 in 168 Countries Correlated Statistically with Biometrics, Socioeconomic Status, Tobacco, Gender, Exercise, Macronutrients, and Vitamin K. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

Six weeks phylloquinone supplementation produces undesirable effects on blood lipids with no changes in inflammatory and fibrinolytic markers in postmenopausal women. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Plasma levels of vitamin K and the risk of ischemic heart disease: a Mendelian randomization study. [2023]