Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04022135
Eligibility Criteria:
Inclusion Criteria:
* Pregnant woman (singleton pregnancy)
* Living in the Greater Vancouver area and willing to travel to the University of British Columbia for study visits
* \<21 weeks gestation
* 19-42 years of age
* willing to participate
Exclusion Criteria:
* Have a pre-existing medical condition known to impact maternal folate status (malabsorptive of irritable bowel disease, active celiac disease, gastric bypass surgery, atrophic gastritis, epilepsy, advanced liver disease, kidney dialysis, type 1 or 2 diabetes mellitus, sickle cell trait/anemia)
* Lifestyle factors known to impact maternal folate status (smoking, alcohol overuse, non-prescription drug use/abuse)
* Are medium to high risk for development of an NTD-affected pregnancy (applies to women or their male partner: personal or family history \[parents or siblings\] of other folate sensitive congenital anomalies, personal NTD history or a previous NTD-affected pregnancy)
* Are taking medications known to interfere with B-vitamin metabolism (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates)
* pre-pregnancy body mass index ≥30 kg/m2
* allergic to any of the supplement ingredients
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
42 Years
Study:
NCT04022135
Study Brief:
Protocol Section:
NCT04022135