Status:
COMPLETED
Natural Folate vs. Synthetic Folic Acid in Pregnancy
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
BC Children's Hospital Research Institute
Conditions:
Pregnancy
Eligibility:
FEMALE
19-42 years
Phase:
NA
Brief Summary
In this two-arm, double-blind randomized pilot study, the investigators will recruit 60 generally healthy, low-risk pregnant women aged 19-42 years living in Vancouver, Canada. Participants will be ra...
Detailed Description
A sample size of 50 women (25 in each group) are required to reliably estimate the distributions of serum and red blood cell folate. Thus, to account for drop outs or loss to follow up, a total of 60 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04022135
Start Date
September 16 2019
End Date
September 8 2021
Last Update
April 14 2023
Active Locations (1)
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1
University of British Columbia, Food Nutrition and Health Building
Vancouver, British Columbia, Canada, V6T 1Z4