PREconception Folic Acid Clinical Efficacy (PREFACE) Trial | NCT06641245

Studies
PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

NCT06641245

Sponsor

University of British Columbia

Status

Not yet recruiting

Last Update Posted

Oct 21, 2024Actual

Enrollment

272Estimated

Phase

Not Applicable

Conditions

Folate
Folate Bioavailability
Clinical Trials
Pregnancy

Interventions

Folic Acid
5-MTHF (5-methyltetrahydrofolate)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UBC CREB H24-01716	Other Identifier	The University of British Columbia (UBC) Clinical Research Ethics Board (CREB)

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2025Estimated

Primary Completion Date

Jan 31, 2029Estimated

Completion Date

Jan 31, 2030Estimated

First Submitted Date

Oct 11, 2024

First Submission Date that Met QC Criteria

Oct 11, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2024

Last Update Posted Date

Oct 21, 2024Actual

Name	Class
University of Saskatchewan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

272Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5MTHF	Experimental	5MTHF	Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)
Synthetic folic acid	Active Comparator	Folic acid	Dietary Supplement: Folic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Folic Acid	Dietary Supplement	folic acid (0.6 mg)	Synthetic folic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RBC folate	•Maternal RBC folate concentrations (nmol/L)	At 6 (± 2) wks gestation (approximate time of neural tube closure)

Secondary Outcomes

Measure	Description	Time Frame
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	At 18 (± 1) and 30 (± 1) wks gestation

Other Outcomes

Measure	Description	Time Frame
Human milk total folate concentrations	Unmetabolized folic acid, reduced folate forms (nmol/L), and folate binding protein	At 4 weeks postpartum

Eligibility Module

Eligibility Criteria

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:

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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Crystal D Karakochuk, PhD	Contact	604-822-0421		crystal.karakochuk@ubc.ca

Overall Officials

Name	Affiliation	Role
Crystal D Karakochuk, PhD	The University of British Columbia	Principal Investigator
Kelsey M Cochrane, PhD	University of Saskatchewan	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005492	Folic Acid
C005984	5-methyltetrahydrofolate

Ancestor Terms

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

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Browse Branches

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