Clinical Trials, Folate, Folate Bioavailability, Pregnancy
Conditions
Keywords
Folic acid, Folate, Methylfolate, 5-MTHF, RBC Folate, Placental Growth Factor
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).
Interventions
DIETARY_SUPPLEMENTFolic Acid
folic acid (0.6 mg)
DIETARY_SUPPLEMENT5-MTHF (5-methyltetrahydrofolate)
0.625 mg/d (6S)-5-MTHF
Sponsors
University of Saskatchewan
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A double-blind randomized non-inferiority trial
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 42 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC folate | At 6 (± 2) wks gestation (approximate time of neural tube closure) | •Maternal RBC folate concentrations (nmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal plasma placental growth factor (pg/mL) | At 18 (± 1) and 30 (± 1) wks gestation | A novel biomarker with increasing use in clinical practice due to a discriminatory capacity for fetal growth restriction vs a small, but healthy fetus |
Other
| Measure | Time frame | Description |
|---|---|---|
| Human milk total folate concentrations | At 4 weeks postpartum | Unmetabolized folic acid, reduced folate forms (nmol/L), and folate binding protein |
Contacts
Primary ContactCrystal D Karakochuk, PhD
Outcome results
None listed