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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
≥ 1-year amenorrhea
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 2 hours after placebo or folic acid consumption
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not had a menstrual period for at least 1 year.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial sensitivity to shear rate
Secondary outcome measures
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
120 Previous Clinical Trials
68,779 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this research study?

"Affirmative, the data on clinicaltrials.gov shows that this scientific exploration is in search of volunteers. This research project, which was inaugurated on May 16th 2019, has recently been updated and now requires 40 participants from a single location."

Answered by AI

Is eligibility for this trial open to me?

"Entry into this clinical trial necessitates that applicants are post-menopausal and fall between the age of 50 to 80. The total number of participants sought is 40."

Answered by AI

Are there any current opportunities to register for this research?

"Affirmative. According to the data presented on clinicaltrials.gov, this trial is still actively recruiting patients since it was first posted in May 2019 and last updated in May 2021. Forty individuals are expected to participate at one location."

Answered by AI

Does this clinical trial permit individuals under the age of 35 to participate?

"The eligibility requirements for this trial mandate that participants must be aged 50-80."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024