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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Vitamin K can improve brain function and blood vessel health in individuals with stable coronary heart disease, a condition affecting the heart's blood supply. Participants will receive either a daily dose of Vitamin K or a placebo (a pill with no active ingredient) for 12 weeks. The trial seeks participants who have stable coronary heart disease, do not currently take Vitamin K supplements, and can understand French or English well. As an unphased trial, it offers a unique opportunity to contribute to understanding the potential health benefits of Vitamin K.

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 there any evidence suggesting that Vitamin K supplementation is likely to be safe for humans?

Research has shown that increased vitamin K intake is linked to a lower risk of heart disease and other serious health issues. Specifically, individuals who consumed high amounts of vitamin K1 were 21% less likely to require hospital care for heart problems due to blocked arteries. This suggests potential heart health benefits from vitamin K.

Although few studies have focused specifically on vitamin K and heart disease, the current evidence is encouraging. Vitamin K, already present in many diets, is generally considered safe and aids in blood clotting and bone health. This history of safe use makes it a promising candidate for further research, such as this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for heart disease typically involve medications like statins, beta-blockers, or ACE inhibitors, which work by managing cholesterol levels, blood pressure, or heart rhythm. However, Vitamin K is unique because it is a natural dietary supplement that may improve heart health by influencing calcium regulation and preventing artery calcification. Researchers are excited about it because it offers a potential new approach by targeting the underlying processes of vascular calcification, which standard medications do not directly address. This could provide an innovative and complementary option to existing treatments, potentially leading to better overall cardiovascular health.

What evidence suggests that Vitamin K might be an effective treatment for heart disease?

Research has shown that vitamin K, particularly vitamin K2, might improve heart health by reducing arterial stiffness and slowing calcium build-up in blood vessels. One study found that people who consumed more vitamin K1 had an 8% lower chance of heart disease. Another study revealed that individuals with low vitamin K1 levels in their blood faced a 19% higher risk of dying from any cause. Additionally, higher vitamin K1 intake was linked to a lower risk of death from heart issues in older women. While vitamin K1 didn't directly lower heart disease risk, vitamin K2 did. These findings suggest that vitamin K may support heart health in people with coronary heart disease (CHD). Participants in this trial will receive either vitamin K or a placebo to further investigate these potential benefits. ^{2 6 7 8 9}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8596038/

Vitamin K2—a neglected player in cardiovascular health Increased vitamin K2 intake may reduce arterial stiffness, slow progression of vascular and valvular calcification, lower the incidence of ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.020551

Vitamin K Intake and Atherosclerotic Cardiovascular ... In the same study, the authors observed an 8% lower risk of total coronary heart disease events for vitamin K1 (4249 events),,,, and a 30% lower ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522011248

a participant-level meta-analysis of 3 US cohorts Participants with ≤0.5 nmol/L circulating phylloquinone had an adjusted 19% higher risk of all-cause mortality compared with those with >1.0 nmol/L [fully ...

4. nmcd-journal.com nmcd-journal.com/article/S0939-4753(23)00501-X/fulltext

Vitamin K1 intake is associated with lower risk for all-cause ... Higher vitamin K1 intakes were associated with lower risk for both all-cause and CVD mortality in community-dwelling older women, independent of ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/10/5/e035953

Association of dietary vitamin K and risk of coronary heart ... Higher intake of vitamin K2 was associated with lower risk of CHD, while there was no association between intake of vitamin K1 and CHD.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/VitaminK-HealthProfessional/

Vitamin K - Health Professional Fact Sheet Despite these data, few trials have investigated the effects of vitamin K supplementation on arterial calcification or coronary heart disease ...

7. health.harvard.edu health.harvard.edu/heart-health/diets-rich-in-vitamin-k-linked-to-lower-heart-disease-risk

Diets rich in vitamin K linked to lower heart disease risk People with the highest vitamin K1 intakes were 21% less likely to be hospitalized with cardiovascular disease caused by clogged arteries ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S093947532300501X

Vitamin K1 intake is associated with lower risk for all-cause ... Higher vitamin K1 intakes were associated with lower risk for both all-cause and CVD mortality in community-dwelling older women, independent of CVD related ...

9. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)01124-8/fulltext

Vitamin K status, cardiovascular disease, and all-cause mortality Vitamin K-dependent proteins in vascular tissue affect vascular stiffness and calcification, which is associated with cardiovascular disease (CVD) and all-cause ...