Vitamin K and Cognition in Coronary Heart Disease (NutriCog)
Nutricog
Vitamin K Supplementation to Improve Cognition of Patients With Coronary Heart Disease: a Randomized Controlled Pilot Study
2 other identifiers
interventional
40
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedStudy Start
First participant enrolled
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 4, 2025
February 1, 2025
1.7 years
February 20, 2025
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in general cognitive functioning
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning)
Baseline and post-intervention at 12 weeks
Change in processing speed
Processing speed is assessed using the Coding subtest from the Wechsler Adult Intelligence Scale (WAIS)IV. The participant is asked to reproduce, as rapidly as possible, a series of symbols associated with digits in a 2-min time period
Baseline and post-intervention at 12 weeks
Change in executive functions
Executive function is assessed using 1. Delis-Kaplan Executive Function System (D-KEFS) subtests \[Trail Making Test; Phonological and Semantic Fluency test \[Letters P, T, L (60s maximum); Categories: animals, men's names (60s maximum)\] 2. WAISIV subtests ("Switching" between naming fruit and furniture (60s maximum)\] 3. Neuropeak platform developed by Dr Bherer's laboratory: dual-task (divided attention) and n-back (working memory and updating). These tasks are tablet/computer-based As these tests use different scales, z-scores will be calculated for the different tests and a composite z-score will be generated for the domain
Baseline and post-intervention at 12 weeks
Change in episodic memory
Episodic memory is assessed using: 1. Rey auditory verbal learning test (RAVLT). Score 0-75, with a higher score indicating a better memory 2. Digit span, a test that requires participants to repeat series of digits of increasing length As these tests use different scales, z-scores will be calculated for the different tests and a composite z-score will be generated for the domain
Baseline and post-intervention at 12 weeks
Secondary Outcomes (4)
Change in cerebral autoregulation - middle cerebral arteries
Baseline and post-intervention at 12 weeks
Change in cerebral pulsatility - middle cerebral arteries
Baseline and post-intervention at 12 weeks
Change in peripheral endothelial function
Baseline and post-intervention at 12 weeks
Central arterial stiffness
Baseline and post-intervention at 12 weeks
Study Arms (2)
Dietary Supplement: Vitamin K
EXPERIMENTALParticipants receive 0.5 mg/day phylloquinone orally for 12 weeks
Dietary Supplement: Placebo
PLACEBO COMPARATORParticipants receive daily placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guylaine Ferland, PhD
Université de Montréal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2025
First Posted
March 4, 2025
Study Start
March 17, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Study protocol will be submitted for publication once the study registration process is completed
The study protocol will be published