PregnancyNCT04022135
Natural Folate vs. Synthetic Folic Acid in Pregnancy
A study testing Folic acid and (6S)-5-methyltetrahydrofolic acid in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial 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 randomized to supplement with either 0.6 mg/day folic acid or an equimolar dose (0.625 mg/day) of… Read more about this study
- Who is it for?
- Ages 19 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Folic acid and (6S)-5-methyltetrahydrofolic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2019to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Food Nutrition and Health Building
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: Is Natural Folate as Effective as Synthetic Folic Acid in Increasing Serum and Red Blood Cell Folate Concentrations During Pregnancy? A Proof-of-concept Pilot Study
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 randomized to supplement with either 0.6 mg/day folic acid or an equimolar dose (0.625 mg/day) of (6S)-5-methyltetrahydrofolic acid for 16-weeks of their pregnancy. Randomization will occur at 8-21 weeks gestation (after neural tube closure) to reduce the risk of harm should the natural folate prove less effective. All participants will also receive a prenatal multivitamin not containing any form of folate, to ensure adequacy of other nutrients (e.g. iron) required during pregnancy. Three-hour fasting venous blood samples will be collected at baseline and endline to measure serum and red blood cell folate, unmetabolized folic acid and other related biomarkers. Women will be given the option to continue supplementing until 1-week postpartum, and provide a small (3mL) breastmilk sample and blood sample in order to measure differences in folates in breastmilk and postpartum folate. These pilot data will be used to inform a definitive trial regarding the most effective form of folate supplementation for mothers and their babies.
Read the 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 women (30 in each group) will be recruited.
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
- Pregnancy
- Being tested
- Folic acid, (6S)-5-methyltetrahydrofolic acid
- Keywords
- folate, folic acid, nutrition, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDietary supplement
Participants will supplement with 0.6mg/day for 16 weeks.
(6S)-5-methyltetrahydrofolic acidDietary supplement
Also called Metafolin
Participants will supplement with 0.625mg/day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Folic acid | Active comparator | 0.6 mg/day Receives: Dietary Supplement: Folic acid |
| (6S)-5-methyltetrahydrofolic acid (Metafolin) | Experimental | 0.625 mg/d (an equimolar dose to folic acid) Receives: Dietary Supplement: (6S)-5-methyltetrahydrofolic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of red blood cell folate levels
nmol/L; Reflects longer term status (e.g. previous 3-4 months)
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
Concentration of serum folate levels
nmol/L; Reflects recent status or dietary intake
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
Concentration of unmetabolized folic acid (and other folate forms: THF, 5-Methyl-THF, 5-formyl-THF, and 5,10-methenyl-THF)
nmol/L; unmetabolized folic acid is not incorporated into RBCs, rather it circulates in plasma
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
Secondary outcomes (18)
Concentration of total vitamin B-12
pmol/mL; closely involved in folate metabolism and facilitating methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of pyridoxal-5'-phosphate
nmol/L; closely involved in folate metabolism and facilitating methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of vitamin B2
nmol/L; closely involved in folate metabolism and facilitating methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of betaine
µmol/L; closely involved in facilitating methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of choline
µmol/L; closely involved in facilitating methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of dimethylglycine
µmol/L; closely involved in facilitating methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of S-adenosyl-methionine
µM; Metabolite produced in methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of S-adenosyl-homocysteine
µM; Metabolite produced in methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of total homocysteine
µmol/L; Metabolite produced in methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of methionine
µmol/L; Metabolite produced in methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of cysteine
µmol/L; Metabolite produced in methionine cycles
Measured: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Collection of peripheral blood mononuclear layer cells
Gene variant assessment of MTHFR (677 C>T, rs1801133, and 1298 A>C, rs1801131) and DHFR (rs1643649 and rs70991108) and differences in DNA methylation, and frequency and cytotoxicity of immune cells in PBMCs.
Measured: Collection at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of unmetabolized folic acid in breastmilk (and other folate forms: THF, 5-Methyl-THF, 5-formyl-THF, and 5,10-methenyl-THF)
nmol/L; folic acid that is unmetabolized and enters breastmilk as such
Measured: Collection at 1 week postpartum
Folate binding protein in breastmilk
nmol folate binding per liter of milk
Measured: Collection at 1 week postpartum
Breastmilk fatty acids & choline forms (free choline, betaine, phosphocholine, glycerophosophocholine)
Quantified via LC-MS/MS
Measured: Collection at 1 week postpartum
Breastmilk human milk oligosaccharides and breastmilk microbiome
Quantified via HPLC-FL and PCR
Measured: Collection at 1 week postpartum
Complete blood count
Analysis will be performed using an automated hematology analyzer (Sysmex XNL550, Kobe, Japan)
Measured: Baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
Markers of Iron and Inflammation
This will include measurement of serum ferritin (µg/L), soluble transferrin receptor (mg/L), body iron stores (mg/kg), retinol binding protein (µmol/L), CRP (mg/L), and AGP (g/L) in serum using a sandwich ELISA, and hormones that influence iron regulation in pregnancy, including serum hecipdin (ng/mL; measured with an ELISA) and serum erythropoietin (mIU/mL; measured with an immunoassay)
Measured: Baseline (8-21 weeks gestation),and endline (24-37 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Sep 2019
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Responsible party
- Principal investigator, Crystal Karakochuk, University of British Columbia
- Investigators
- Crystal Karakochuk, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022135
- Sponsor's protocol ID
- H18-02635
- Status last verified
- Apr 2023
- First submitted
- 14 Jul 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification, will be available immediately following publication. Anyone who is interested in accessing the data should send a proposal to the principal investigator for approval to gain access.
Publications
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.
PubMed 35687377Cochrane 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.
PubMed 32370802
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Natural Folate as Effective as Synthetic Folic Acid in Increasing Serum and Red Blood Cell Folate Concentrations During Pregnancy? A Proof-of-concept Pilot Study
- ClinicalTrials.gov ID
- NCT04022135
- Acronym / sponsor ID
- H18-02635
- Conditions
- Pregnancy
- Keywords
- folate, folic acid, nutrition, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 randomized to supplement with either 0.6 mg/day folic acid or an equimolar dose (0.625 mg/day) of (6S)-5-methyltetrahydrofolic acid for 16-weeks of their pregnancy. Randomization will occur at 8-21 weeks gestation (after neural tube closure) to reduce the risk of harm should the natural folate prove less effective. All participants will also receive a prenatal multivitamin not containing any form of folate, to ensure adequacy of other nutrients (e.g. iron) required during pregnancy. Three-hour fasting venous blood samples will be collected at baseline and endline to measure serum and red blood cell folate, unmetabolized folic acid and other related biomarkers. Women will be given the option to continue supplementing until 1-week postpartum, and provide a small (3mL) breastmilk sample and blood sample in order to measure differences in folates in breastmilk and postpartum folate. These pilot data will be used to inform a definitive trial regarding the most effective form of folate supplementation for mothers and their babies.
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 women (30 in each group) will be recruited.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid | Active comparator | Dietary Supplement: Folic acid0.6 mg/day |
| (6S)-5-methyltetrahydrofolic acid (Metafolin) | Experimental | Dietary Supplement: (6S)-5-methyltetrahydrofolic acid0.625 mg/d (an equimolar dose to folic acid) |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acidParticipants will supplement with 0.6mg/day for 16 weeks. | Dietary supplement | Folic acid |
| (6S)-5-methyltetrahydrofolic acidAlso: MetafolinParticipants will supplement with 0.625mg/day for 16 weeks. | Dietary supplement | (6S)-5-methyltetrahydrofolic acid (Metafolin) |
Primary outcome
Concentration of red blood cell folate levels
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
nmol/L; Reflects longer term status (e.g. previous 3-4 months)
Concentration of serum folate levels
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
nmol/L; Reflects recent status or dietary intake
Concentration of unmetabolized folic acid (and other folate forms: THF, 5-Methyl-THF, 5-formyl-THF, and 5,10-methenyl-THF)
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
nmol/L; unmetabolized folic acid is not incorporated into RBCs, rather it circulates in plasma
18 secondary outcomes
Concentration of total vitamin B-12
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of pyridoxal-5'-phosphate
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of vitamin B2
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of betaine
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of choline
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of dimethylglycine
Time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of S-adenosyl-methionine
Time frame: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of S-adenosyl-homocysteine
Time frame: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of total homocysteine
Time frame: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of methionine
Time frame: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Concentration of cysteine
Time frame: concentrations at both baseline (8-21 weeks gestation) and endline (24-37 weeks gestation)
Collection of peripheral blood mononuclear layer cells
Time frame: Collection at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation)
Concentration of unmetabolized folic acid in breastmilk (and other folate forms: THF, 5-Methyl-THF, 5-formyl-THF, and 5,10-methenyl-THF)
Time frame: Collection at 1 week postpartum
Folate binding protein in breastmilk
Time frame: Collection at 1 week postpartum
Breastmilk fatty acids & choline forms (free choline, betaine, phosphocholine, glycerophosophocholine)
Time frame: Collection at 1 week postpartum
Breastmilk human milk oligosaccharides and breastmilk microbiome
Time frame: Collection at 1 week postpartum
Complete blood count
Time frame: Baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum
Markers of Iron and Inflammation
Time frame: Baseline (8-21 weeks gestation),and endline (24-37 weeks gestation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 35687377Cochrane 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.
- Derived from this study: PubMed 32370802Cochrane 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification, will be available immediately following publication. Anyone who is interested in accessing the data should send a proposal to the principal investigator for approval to gain access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Karakochuk, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid and (6S)-5-methyltetrahydrofolic acid in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of red blood cell folate levels (time frame: concentrations at both baseline (8-21 weeks gestation), endline (24-37 weeks gestation), and postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022135, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.