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Vitamin

Folic Acid for Vascular Health in Post-Menopausal Women

N/A
Recruiting
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
For female participants, having undergone an ovariectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 2 hours after placebo or folic acid consumption

Summary

This trial will evaluate if folic acid can help improve the sensitivity of blood vessel linings in post-menopausal women.

Who is the study for?
This trial is for post-menopausal women who are non-smokers, have not smoked for at least a year, and have had no menstrual periods for over a year. They should be relatively healthy with a BMI of 30 or less and normal blood pressure. Women with heart, lung, brain diseases or metabolic disorders, those on related medications, or who've had their ovaries removed can't join.
What is being tested?
The study is testing whether folic acid supplements can help improve the way blood vessels respond to changes in blood flow in older women compared to a placebo (a substance with no active drug). Participants will randomly receive either folic acid or placebo to see if there's any difference.
What are the potential side effects?
Folic acid is generally considered safe but may cause mild side effects like upset stomach, sleep disturbances, skin reactions or confusion. The placebo is inactive and unlikely to cause any direct side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had my ovaries surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 2 hours after placebo or folic acid consumption
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 2 hours after placebo or folic acid consumption for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endothelial sensitivity to shear rate
Secondary study objectives
Neurovascular transduction

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Folic AcidExperimental Treatment1 Intervention
Participant will be asked to ingest a capsule containing 5 mg of folic acid.
Group II: Placebo treatmentPlacebo Group1 Intervention
Participant will be asked to ingest a placebo capsule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folic Acid
2008
Completed Phase 4
~7610

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
123 Previous Clinical Trials
79,362 Total Patients Enrolled
2 Trials studying Aging
296 Patients Enrolled for Aging

Media Library

Folic Acid (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04016090 — N/A
Aging Research Study Groups: Folic Acid, Placebo treatment
Aging Clinical Trial 2023: Folic Acid Highlights & Side Effects. Trial Name: NCT04016090 — N/A
Folic Acid (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04016090 — N/A
~6 spots leftby Dec 2025
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