Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

Last updated: February 25, 2025
Sponsor: Montreal Heart Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Atherosclerosis

Vascular Diseases

Treatment

Placebo

Vitamin K

Clinical Study ID

NCT06855953
2022-3025
(FRN) 183781_1
  • Ages > 60
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women

  • Age 60 years and older

  • Medically documented stable Coronary Heart Disease (CHD)

  • Daily dietary intakes of phylloquinone <150 mcg

  • Non-consumption of vitamin K supplements (i.e. K1 or K2, singly or in combinationwith other nutrients), or other cognitive aids

  • Good French or English understanding

  • Physical exercise not exceeding 2.5 hours/week of moderate to vigorous aerobicactivity

  • Capacity and willingness to sign informed consent

Exclusion

Exclusion Criteria:

  • Recent acute coronary syndrome (<3 months) or recent coronary revascularization (bypass surgery or percutaneous coronary intervention, <3 months)

  • Known left ventricular dysfunction (LVEF < 40%) or chronic heart failure

  • Recent modification of medication (<2 weeks)

  • Warfarin (Coumadin) use

  • Cognitive impairment (based on telephone version of the Mini-Mental StateExamination test, score <19/23)

  • Diagnosis of depression or uncontrolled anxiety

  • Malabsorption disorder (advanced liver disease, Crohn's disease)

  • Patient with auditory or vision impairments not properly corrected by glasses orhearing aids

  • Unable to read the informed consent form or unable to understand the oralexplanations provided by the assessor

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
March 17, 2025
Estimated Completion Date:
March 31, 2027

Study Description

The overall goal of this study is to obtain a preliminary assessment of the effect of a VK1 (phylloquinone) supplementation on cognitive performance (primary outcome) and vascular function (secondary outcome) in adults with stable CHD. Specifically, the investigators will conduct a double-blind, 2-armed, parallel-group intervention study in which 40 men and women aged 60 years and over with stable CHD will be randomly assigned to 0.5 mg phylloquinone per day or matching placebo for a period of 3 months. All participants will have signed a written consent form before taking part in the study

Connect with a study center

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

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