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Not yet recruiting NCT06855953

Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

No phase Interventional Coronary Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin K, Placebo.
Who it may be relevant to
Registry conditions: Coronary Heart Disease. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Vitamin K Supplementation to Improve Cognition of Patients With Coronary Heart Disease: a Randomized Controlled Pilot Study

Overview

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)

Detailed 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

Interventions

  • Dietary supplement Vitamin K
    Participants receive 0.5 mg/day phylloquinone orally for 12 weeks
  • Dietary supplement Placebo
    Participants receive daily placebo for 12 weeks

Primary outcome measures

  • Change in general cognitive functioning [Time frame: Baseline and post-intervention at 12 weeks]
  • Change in processing speed [Time frame: Baseline and post-intervention at 12 weeks]
  • Change in executive functions [Time frame: Baseline and post-intervention at 12 weeks]
  • Change in episodic memory [Time frame: Baseline and post-intervention at 12 weeks]
Secondary outcome measures (4)
  • Change in cerebral autoregulation - middle cerebral arteries [Time frame: Baseline and post-intervention at 12 weeks]
  • Change in cerebral pulsatility - middle cerebral arteries [Time frame: Baseline and post-intervention at 12 weeks]
  • Change in peripheral endothelial function [Time frame: Baseline and post-intervention at 12 weeks]
  • Central arterial stiffness [Time frame: Baseline and post-intervention at 12 weeks]

Eligibility criteria

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 combination with other nutrients), or other cognitive aids
  • Good French or English understanding
  • Physical exercise not exceeding 2.5 hours/week of moderate to vigorous aerobic activity
  • Capacity and willingness to sign informed consent

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 State Examination 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 or hearing aids
  • Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Canada · 1 center
  • Montreal Heart Institute — Montreal

Identifiers

NCT: NCT06855953 · 2022-3025 · (FRN) 183781_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗