FolatePREFACENCT06641245
PREconception Folic Acid Clinical Efficacy (PREFACE) Trial
A study testing Folic Acid and 5-MTHF (5-methyltetrahydrofolate) in people with Folate and Folate Bioavailability, run by University of British Columbia.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Folate, Folate Bioavailability, Clinical Trials
- What is being tested?
- Folic Acid and 5-MTHF (5-methyltetrahydrofolate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2025to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-pregnant females who are:
- Currently trying to become pregnant;
- Aged 19-42 years;
- Low risk for an NTD-affected pregnancy
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
- Conditions
- Folate, Folate Bioavailability, Clinical Trials, Pregnancy
- Being tested
- Folic Acid, 5-MTHF (5-methyltetrahydrofolate)
- Keywords
- Folic acid, Folate, Methylfolate, 5-MTHF, RBC Folate, Placental Growth Factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDietary supplement
folic acid (0.6 mg)
5-MTHF (5-methyltetrahydrofolate)Dietary supplement
0.625 mg/d (6S)-5-MTHF
| Study group | Role | What they receive |
|---|---|---|
| 5MTHF | Experimental | 5MTHF Receives: Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate) |
| Synthetic folic acid | Active comparator | Folic acid Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC folate
•Maternal RBC folate concentrations (nmol/L)
Measured: 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
Measured: At 18 (± 1) and 30 (± 1) wks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Jan 2025 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FolateStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind randomized non-inferiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan
- Responsible party
- Principal investigator, Crystal Karakochuk, University of British Columbia
- Investigators
- Crystal D Karakochuk, PhD, Principal investigator, The University of British ColumbiaKelsey M Cochrane, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641245
- Sponsor's protocol ID
- H24-01716
- Other IDs
- UBC CREB H24-01716
- Acronym
- PREFACE
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREconception Folic Acid Clinical Efficacy (PREFACE) Trial
- ClinicalTrials.gov ID
- NCT06641245
- Acronym / sponsor ID
- PREFACE / H24-01716
- Conditions
- Folate, Folate Bioavailability, Clinical Trials, Pregnancy
- Keywords
- Folic acid, Folate, Methylfolate, 5-MTHF, RBC Folate, Placental Growth Factor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Saskatchewan
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomized non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| 5MTHF | Experimental | Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)5MTHF |
| Synthetic folic acid | Active comparator | Dietary Supplement: Folic AcidFolic acid |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-pregnant females who are:
- Currently trying to become pregnant;
- Aged 19-42 years;
- Low risk for an NTD-affected pregnancy
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acidfolic acid (0.6 mg) | Dietary supplement | Synthetic folic acid |
| 5-MTHF (5-methyltetrahydrofolate)0.625 mg/d (6S)-5-MTHF | Dietary supplement | 5MTHF |
Primary outcome
RBC folate
Time frame: At 6 (± 2) wks gestation (approximate time of neural tube closure)
•Maternal RBC folate concentrations (nmol/L)
1 secondary outcome
Maternal plasma placental growth factor (pg/mL)
Time frame: At 18 (± 1) and 30 (± 1) wks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Crystal D Karakochuk, PhD principal investigator
The University of British Columbia
Kelsey M Cochrane, PhD principal investigator
University of Saskatchewan
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid and 5-MTHF (5-methyltetrahydrofolate) in people with Folate and Folate Bioavailability, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal D Karakochuk, PhD (604-822-0421, crystal.karakochuk@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC folate (time frame: At 6 (± 2) wks gestation (approximate time of neural tube closure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.