ClinicalTrials.gg
Not yet recruitingNCT06641245PREFACEUpdated Oct 21, 2024

PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

An interventional study of Folic Acid and 5-MTHF (5-methyltetrahydrofolate) in Folate, Folate Bioavailability and Clinical Trials, sponsored by University of British Columbia. Not yet recruiting. Open to female participants aged 19 Years to 42 Years. Per ClinicalTrials.gov, last updated 2024-10-21.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
272
Allocation
Randomized
Ages
19 Years to 42 Years
Sex
Female
01

Study summary

A study to help understand what forms of folic acid are most effective to increase folate status during pregnancy for the best protection against neural tube defects

Read the detailed description

A multisite randomized controlled trial to determine whether supplementation with (6S)-5-methyltetrahydrofolic acid (5-MTHF) is at least as effective as synthetic folic acid in increasing maternal folate status for protection against neural tube defects (NTDs).

02

Conditions studied

  • Folate
  • Folate Bioavailability
  • Clinical Trials
  • Pregnancy

Keywords

  • Folic acid
  • Folate
  • Methylfolate
  • 5-MTHF
  • RBC Folate
  • Placental Growth Factor
03

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-pregnant females who are:
  • Currently trying to become pregnant;
  • Aged 19-42 years;
  • Low risk for an NTD-affected pregnancy

Exclusion criteria

Exclusion Criteria:

  • Trying to conceive for ≥6 months (as \~90% of pregnancies occur after 6 months of trying);
  • Diagnosed ovulatory disorders (polycystic ovary syndrome, endometriosis, or menstrual irregularity);
  • More than 2 miscarriages in the past year;
  • Undergoing fertility assistance (including current IVF or intrauterine insemination);
  • Pre-existing medical condition known to impact maternal folate status (malabsorptive and inflammatory bowel diseases, active celiac disease, gastric bypass surgery, type 1 or 2 diabetes mellitus);
  • Lifestyle factors known to impact maternal folate status (current smoking, >6 alcoholic drinks per week, recreational drug use);
  • On the female or male side of those trying to conceive: personal NTD history, previous NTD-affected pregnancy, or personal or family history of other folate sensitive congenital anomalies;
  • Use of folate-inhibiting medications (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
272 participants (estimated)

Study arms

  • Experimental
    5MTHF

    5MTHF

    Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)

  • Active comparator
    Synthetic folic acid

    Folic acid

    Dietary Supplement: Folic Acid

Interventions

06

What researchers measure

Primary outcomes

  1. RBC folate

    •Maternal RBC folate concentrations (nmol/L)

    Time frame: At 6 (± 2) wks gestation (approximate time of neural tube closure)

Secondary outcomes

  1. Maternal plasma placental growth factor (pg/mL)

    A novel biomarker with increasing use in clinical practice due to a discriminatory capacity for fetal growth restriction vs a small, but healthy fetus

    Time frame: At 18 (± 1) and 30 (± 1) wks gestation

Other outcomes

  1. Human milk total folate concentrations

    Unmetabolized folic acid, reduced folate forms (nmol/L), and folate binding protein

    Time frame: At 4 weeks postpartum

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Jan 2029, 48 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2024
First posted
Oct 15, 2024
StartEst.
Jan 31, 2025
Primary completionEst.
Jan 31, 2029
CompletionEst.
Jan 31, 2030
Last update
Oct 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06641245
Responsible party
Crystal Karakochuk (Associate Professor, Human Nutrition, University of British Columbia) — Principal investigator
First posted
Oct 15, 2024
Start date
Jan 31, 2025 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2030 (estimated)
Last update
Oct 21, 2024

Study contacts

Crystal D Karakochuk, PhD
Contact
crystal.karakochuk@ubc.ca
604-822-0421
Crystal D Karakochuk, PhD
principal investigator · The University of British Columbia
Kelsey M Cochrane, PhD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Levomefolic acid

Start the discussion