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Grant: Project Grant

University of British Columbia

$634,950.00

Non-inferiority of (6S)-5-MTHF as compared to synthetic folic acid in increasing maternal folate status during pregnancy: A randomized controlled trial

FY 2023-24

Summary
Folic acid is a man-made form of folate that is recommended to reduce the risk of birth defects in early pregnancy. However, natural folate is increasingly added to supplements in place of folic acid. We recently conducted a survey among people who were pregnant or trying to get pregnant in Vancouver, BC, and found that almost 20% of people were supplementing with natural folate instead of folic acid. It is unknown whether natural folate is as effective as folic acid in increasing blood folate levels during pregnancy to reduce the risk of birth defects. To address this gap, we plan to enrol 250 people who are trying to become pregnant in Vancouver, BC, to supplement with natural folate or folic acid. Our primary aim is to ensure that supplementation with natural folate is as effective as folic acid in increasing maternal blood folate status by early pregnancy (6 weeks' gestation); as effective as will be considered a difference in red blood cell folate concentrations no greater than 200 nmol/L. As a secondary aim, we will measure unused folic acid in maternal blood and in umbilical cord blood at delivery. To explore differences in how each folate form impacts fetal growth, we will explore rates of fetal growth restriction in each group by measuring placental growth factor in maternal plasma in later pregnancy (30 weeks' gestation; when this protein peaks in the blood), doing a physical examination of the placenta after delivery for signs of growth restriction, and we will measure RNA (gene) expression in the placenta to explore underlying mechanisms associated with folate and fetal growth restriction. Our results will help to determine the safest and most effective form of folate supplementation to support a healthy pregnancy. While the adverse impacts of unused folic acid for infant health are not fully understood, experts agree that research to better understand the safety concerns associated with folic acid supplementation in pregnancy should be prioritized.
Program
Project Grant
Location
British Columbia, Canada
Recipient Type
Academia
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
489188
Name
Karakochuk Crystal D
Region
British Columbia
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Nutrition, Metabolism and Diabetes
Theme2
Clinical
Prcname2
Nutrition, Food & Health
Projecttitle
Non-inferiority of (6S)-5-MTHF as compared to synthetic folic acid in increasing maternal folate status during pregnancy: A randomized controlled trial
Programtype2
Operating Grants
Orgnameinp2
University of British Columbia
Cihramount2
$634,950
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Folate; Folic Acid; Metabolism; Micronutrients; Pregnancy; Supplementation
Abstract
Folic acid is a man-made form of folate that is recommended to reduce the risk of birth defects in early pregnancy. However, natural folate is increasingly added to supplements in place of folic acid. We recently conducted a survey among people who were pregnant or trying to get pregnant in Vancouver, BC, and found that almost 20% of people were supplementing with natural folate instead of folic acid. It is unknown whether natural folate is as effective as folic acid in increasing blood folate levels during pregnancy to reduce the risk of birth defects. To address this gap, we plan to enrol 250 people who are trying to become pregnant in Vancouver, BC, to supplement with natural folate or folic acid. Our primary aim is to ensure that supplementation with natural folate is as effective as folic acid in increasing maternal blood folate status by early pregnancy (6 weeks' gestation); as effective as will be considered a difference in red blood cell folate concentrations no greater than 200 nmol/L. As a secondary aim, we will measure unused folic acid in maternal blood and in umbilical cord blood at delivery. To explore differences in how each folate form impacts fetal growth, we will explore rates of fetal growth restriction in each group by measuring placental growth factor in maternal plasma in later pregnancy (30 weeks' gestation; when this protein peaks in the blood), doing a physical examination of the placenta after delivery for signs of growth restriction, and we will measure RNA (gene) expression in the placenta to explore underlying mechanisms associated with folate and fetal growth restriction. Our results will help to determine the safest and most effective form of folate supplementation to support a healthy pregnancy. While the adverse impacts of unused folic acid for infant health are not fully understood, experts agree that research to better understand the safety concerns associated with folic acid supplementation in pregnancy should be prioritized.
Competitiondate
202309
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Karakochuk, Crystal D
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $634,950~ $0~