Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-09-16
2021-09-08
Brief Summary
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Detailed Description
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Aim 1: To establish the mean ± standard deviation change in serum folate, red blood cell folate, and unmetabolized folic acid levels in each group following supplementation with (6S)-5-methyltetrahydrofolic acid or folic acid for 16-weeks of pregnancy.
Aim 2: To determine participation recruitment and retention rate, the most effective recruitment strategies for this population, and adherence to study protocol (to inform a definitive trial).
Exploratory Aims: To explore differences in proposed clinical effects associated with folic acid supplementatation (immunity, gene methylation) and differences in biomarkers that function closely with folate in one carbon metabolism (B-vitamins, choline and its metabolites \[betaine, dimethylglycine\]) and which support overall blood health (ferritin, inflammation). In the postpartum phase, we will quantify proportion of total breastmilk folate as folic acid in each group, evaluate correlation of maternal postpartum plasma unmetabolized folic acid and breastmilk folic acid, and to evaluate RBC folate concentrations following delivery in each group. Differences in breastmilk biomarkers associated with folate (choline, human milk oligosaccharides, and breastmilk microbiome) will be explored.
Women may undergo informed consent process anytime \<21 weeks gestation. Once participants indicate that they are interested in participating in the trial, the participant will be given a study ID, and a baseline visit will be scheduled.
The baseline visit will occur between 8-21 weeks gestation, and will involve discontinuation of current folate/prenatal vitamin supplementation, review and signing the informed consent form (a scanned copy will be shared with the participant), randomization to a folate group, provision of study supplements, completion of a baseline questionnaire, completion of a food frequency questionnaire, measurement of weight and height, and a small blood draw (12ml).
Intervention: total time: 16 weeks. Participants will supplement daily with the folate and prenatal vitamin supplements. The research coordinator will call the participants half way through the intervention period to serve as a reminder and answer any questions, which will enhance protocol adherence.
The endline visit will occur between 24-37 weeks gestation, and will involve collecting any remaining supplements (for capsule counts), a weight measurement, and a small blood draw (12ml), and completion of a short endline questionnaire.
Optional continuation of study: After the endline visit, women who are planning to breastfeed will have the option to continue supplementing with the study supplements until approximately 1 week postpartum, at which time they will provide a small (3 mL) breastmilk sample and/or blood sample.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Folic acid
0.6 mg/day
Folic acid
Participants will supplement with 0.6mg/day for 16 weeks.
(6S)-5-methyltetrahydrofolic acid (Metafolin)
0.625 mg/d (an equimolar dose to folic acid)
(6S)-5-methyltetrahydrofolic acid
Participants will supplement with 0.625mg/day for 16 weeks.
Interventions
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Folic acid
Participants will supplement with 0.6mg/day for 16 weeks.
(6S)-5-methyltetrahydrofolic acid
Participants will supplement with 0.625mg/day for 16 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
42 Years
FEMALE
Yes
Sponsors
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BC Children's Hospital Research Institute
OTHER
University of British Columbia
OTHER
Responsible Party
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Crystal Karakochuk
Assistant Professor
Principal Investigators
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Crystal Karakochuk, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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University of British Columbia, Food Nutrition and Health Building
Vancouver, British Columbia, Canada
Countries
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References
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Cochrane KM, Hutcheon JA, Karakochuk CD. Iron-Deficiency Prevalence and Supplementation Practices Among Pregnant Women: A Secondary Data Analysis From a Clinical Trial in Vancouver, Canada. J Nutr. 2022 Oct 6;152(10):2238-2244. doi: 10.1093/jn/nxac135.
Cochrane KM, Mayer C, Devlin AM, Elango R, Hutcheon JA, Karakochuk CD. Is natural (6S)-5-methyltetrahydrofolic acid as effective as synthetic folic acid in increasing serum and red blood cell folate concentrations during pregnancy? A proof-of-concept pilot study. Trials. 2020 May 5;21(1):380. doi: 10.1186/s13063-020-04320-3.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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H18-02635
Identifier Type: -
Identifier Source: org_study_id
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