PregnancyFAPREGNCT02124642
Folic Acid Supplementation in Pregnant Women: Dose Response
A study testing Folic acid, 400 mcg/day and Folic acid 800 mcg/day in people with Pregnancy, run by University of Georgia at 1 site in United States.
Trial summary
The proposed study is a double-blind randomized controlled trial in healthy pregnant women (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery clinic (ARMC). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Folic acid, 400 mcg/day and Folic acid 800 mcg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2017
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women with singleton pregnancy
- < 10 weeks gestation at enrollment
- body mass index 18.5 - 35.0 kg/m2
- willingness to comply with study protocol ( i.e. take assigned daily prenatal vitamin; complete diet recall and study questionnaire)
- not consuming super-fortified ready-to-eat cereal products (with > 100% RDA for folate per serving)
Who cannot join
- BMI < 18.5 or > 35.0 kg/m2
- use of prescription drugs
- anemia
- chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease)
- acute illness (e.g. pneumonia, urinary tract infection, mononucleosis)
- use of antibiotics in past 2 weeks
Show all 12Show fewer
- follows vegan dietary regime
- current smoker
- typical alcohol consumption of 2 or more drinks per day
- having undergone in vitro fertilization treatment
- carrying more than one fetus
- pregnancy-associated complications (i.e gestational diabetes, pre-eclampsia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Athens Regional Medical Center Midwifery Practice
Athens, Georgia, 30606
About this study
The proposed study is a double-blind randomized controlled trial in healthy pregnant women (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery clinic (ARMC).
The primary goal of the proposed study is to determine relative changes in blood folate and DNA methylation levels in response to 2 different supplemental doses of folic acid one of which will provide the Institute of Medicine's recommended folate intake for pregnant women and the second will provide a higher dose as routinely taken by pregnant women in over-the-counter prenatal supplements.
Read more
The specific aims of the study are:
- to compare maternal serum and red blood cell (RBC) folate levels and % change in women taking either 400 or 800 mcg/day of supplemental folic acid from the first prenatal visit (< 10 weeks) through delivery;
- to compare the infant's cord blood folate levels in response to different maternal folic acid intakes (400 mcg/d vs 800 mcg/d);
- to determine relative differences in the levels of oxidized folic acid in maternal and infant blood in response to 400 or 800 mcg/d folic acid dose, and
- to determine genome wide and gene specific DNA methylation response in pregnant women receiving prenatal supplements containing either 400 or 800 mcg folic acid per day
Read the detailed description
The study will be conducted in healthy women with a BMI within the ranges of 18.5 - 35.0 kg/m2. There will be two treatment groups: (1) one group taking 400 mcg per day of folic acid as part of a prenatal supplement, beginning at study enrollment (< 10 weeks gestational age) and (2) a second group taking 800 mcg per day of folic acid as part of the prenatal supplement. Both groups will be provided identical composition of prenatal supplements other than folic acid content. Repeated measures of outcome variables will be determined in blood samples collected at various times during pregnancy and at delivery. Due to the role of prenatal supplementation in helping maintain optimal nutrition status throughout pregnancy, there will be no placebo control.
Women will be recruited through the Athens Regional Medical Center Midwifery Practice and all blood draws associated with this study will be conducted during scheduled prenatal visits. The research protocol is consistent with the standard of care provided by the clinic and will not affect the prenatal services provided to the research participants. Following consent at the first prenatal visit, participants will be randomly assigned to receive prenatal supplements containing either 400 or 800 mcg of folic acid (all other ingredients at unmodified concentrations). The 400 mcg dose approximates the current Recommended Dietary Allowance (RDA) for pregnant women of 600 mcg Dietary Folate Equivalents (400 mcg folic acid ≈ 600 mcg DFEs; conversion factor based on higher bioavailability of folic acid is: 1 mcg folic acid = 1.7 mcg DFE). The higher dose of 800 mcg folic acid represents an amount commonly found in over-the-counter prenatal supplements. Women will be asked to take the supplements daily throughout the duration of gestation and to follow their standard prenatal diet, with the exception of avoiding highly fortified (> 100% RDA) ready-to-eat cereals and fortified energy/snack bars and drinks, due to their high folic acid content.
At the first visit, the participants will be instructed in the use of a dietary recall data collection sheet (food diary) which they will be asked to complete during specific time points during the study. Each set of dietary recalls will include information for three 24-hr periods on non-consecutive days including one weekend day. Dietary recall information will be obtained at approximately weeks 16 and 32 of gestation. This will permit assessment of typical dietary intake of total calories and specific nutrients, including folate.
Blood samples will be collected, in the non-fasting state, at the first, 28 week and 36 week prenatal visits and from the mother and cord blood at delivery for determination of primary outcome measures.
- Conditions
- Pregnancy
- Being tested
- Folic acid, 400 mcg/day, Folic acid 800 mcg/day
- Keywords
- Folate requirements, Pregnancy, Folic acid, DNA methylation, Folate biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acid, 400 mcg/dayDietary supplement
The supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements).
Folic acid 800 mcg/dayDietary supplement
The supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements) and 400 mcg folic acid.
| Study group | Role | What they receive |
|---|---|---|
| Folic acid, 400 mcg/day | Active comparator | A daily 400 microgram (mcg) dose of folic acid will be taken orally, along with the recommended intake for pregnancy of other vitamins, minerals and docosahexaenoic acid (DHA), beginning at enrollment until delivery. The 400 mcg dose approximates the current Recommended Dietary Allowance (RDA) for pregnant women of 600 mcg Dietary Folate Equivalents (400 mcg folic acid ≈ 600 mcg DFEs; conversion factor based on higher bioavailability of folic acid is: 1 mcg folic acid = 1.7 mcg DFE). Receives: Dietary Supplement: Folic acid, 400 mcg/day |
| Folic acid, 800 mcg/day | Experimental | A daily 800 microgram (mcg) dose of folic acid will be taken orally, along with the recommended intake for pregnancy of other vitamins, minerals and docosahexaenoic acid (DHA), beginning at enrollment until delivery. The 800 microgram dose, which is considerably higher than the current RDA, represents an amount commonly found in over-the-counter prenatal vitamin formulations. Receives: Dietary Supplement: Folic acid 800 mcg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum folate
Change in serum folate concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus. Cord blood serum folate at delivery will also be determined by the microbiological assay. Differences in serum folate response to the two levels of folic acid supplementation will be compared.
Measured: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Red blood cell (RBC) folate
Change in red blood cell (RBC) folate concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus. Cord blood RBC folate at delivery will also be determined by the microbiological assay. Differences in RBC folate response to the two levels of folic acid supplementation will be compared.
Measured: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Serum folic acid
Change in serum folic acid concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cord blood serum folic acid at delivery will also be determined by LC-MS/MS. Differences in serum folic acid in response to the two levels of folic acid supplementation will be compared.
Measured: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Gene-specific DNA methylation
Change in DNA methylation in response to folic acid supplementation during pregnancy will be determined in DNA isolated from whole blood. Illumina Infinium HumanMethylatio450 bead chip microarrays will be used to assess changes in multiple methylation sites of specific genes within regulatory pathways for folate metabolism and/or development. Differences in DNA methylation in response to the two levels of folic acid supplementation will be compared.
We anticipate analyzing DNA methylation response at multiple time points and in all participants. Due to the expense associated with the analysis, however, we may be able to perform the analysis only at baseline and delivery and in only a subset of the participants if we are unable to secure additional funding.
Measured: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Secondary outcomes (5)
Cell-type-specific DNA methylation
Change in DNA methylation in response to folic acid supplementation during pregnancy will be determined in DNA isolated from specific white blood cell types obtained by antibody/magnetic technology. Illumina Infinium HumanMethylatio450 bead chip microarrays will be used to assess changes in multiple methylation sites of specific genes within regulatory pathways for folate metabolism and/or development. Differences in DNA methylation in response to the two levels of folic acid supplementation will be compared.
Measured: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Infant birth weight
Birth weight information will be obtained from medical records
Measured: Delivery
Infant length
Length at birth will be obtained from medical records
Measured: Delivery
Infant head circumference
Infant head circumference will be obtained from medical records.
Measured: Delivery
Apgar score
Apgar score of the infant will be obtained from medical records.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Emory University, Cornell University
- Responsible party
- Principal investigator, Lynn B. Bailey, PhD, University of Georgia
- Investigators
- Lynn B Bailey, PhD, Principal investigator, University of GeorgiaDorothy B Hausman, PhD, Study director, University of GeorgiaHea Jin Park, PhD, Study director, University of GeorgiaGail P A Kauwell, PhD, RDN, Study director, University of FloridaMarie A Caudill, PhD, RD, Study director, Cornell UniversityAlicia K Smith, PhD, Study director, Emory Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124642
- Sponsor's protocol ID
- FASUPPPREG-2014
- Acronym
- FAPREG
- Status last verified
- Mar 2018
- First submitted
- 24 Apr 2014
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid Supplementation in Pregnant Women: Dose Response
- ClinicalTrials.gov ID
- NCT02124642
- Acronym / sponsor ID
- FAPREG / FASUPPPREG-2014
- Conditions
- Pregnancy
- Keywords
- Folate requirements, Pregnancy, Folic acid, DNA methylation, Folate biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- University of Florida, Emory University, Cornell University
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Apr 2014 (estimated)
- 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.
The proposed study is a double-blind randomized controlled trial in healthy pregnant women (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery clinic (ARMC).
The primary goal of the proposed study is to determine relative changes in blood folate and DNA methylation levels in response to 2 different supplemental doses of folic acid one of which will provide the Institute of Medicine's recommended folate intake for pregnant women and the second will provide a higher dose as routinely taken by pregnant women in over-the-counter prenatal supplements.
The specific aims of the study are:
- to compare maternal serum and red blood cell (RBC) folate levels and % change in women taking either 400 or 800 mcg/day of supplemental folic acid from the first prenatal visit (< 10 weeks) through delivery;
- to compare the infant's cord blood folate levels in response to different maternal folic acid intakes (400 mcg/d vs 800 mcg/d);
- to determine relative differences in the levels of oxidized folic acid in maternal and infant blood in response to 400 or 800 mcg/d folic acid dose, and
- to determine genome wide and gene specific DNA methylation response in pregnant women receiving prenatal supplements containing either 400 or 800 mcg folic acid per day
Detailed description
The study will be conducted in healthy women with a BMI within the ranges of 18.5 - 35.0 kg/m2. There will be two treatment groups: (1) one group taking 400 mcg per day of folic acid as part of a prenatal supplement, beginning at study enrollment (< 10 weeks gestational age) and (2) a second group taking 800 mcg per day of folic acid as part of the prenatal supplement. Both groups will be provided identical composition of prenatal supplements other than folic acid content. Repeated measures of outcome variables will be determined in blood samples collected at various times during pregnancy and at delivery. Due to the role of prenatal supplementation in helping maintain optimal nutrition status throughout pregnancy, there will be no placebo control.
Women will be recruited through the Athens Regional Medical Center Midwifery Practice and all blood draws associated with this study will be conducted during scheduled prenatal visits. The research protocol is consistent with the standard of care provided by the clinic and will not affect the prenatal services provided to the research participants. Following consent at the first prenatal visit, participants will be randomly assigned to receive prenatal supplements containing either 400 or 800 mcg of folic acid (all other ingredients at unmodified concentrations). The 400 mcg dose approximates the current Recommended Dietary Allowance (RDA) for pregnant women of 600 mcg Dietary Folate Equivalents (400 mcg folic acid ≈ 600 mcg DFEs; conversion factor based on higher bioavailability of folic acid is: 1 mcg folic acid = 1.7 mcg DFE). The higher dose of 800 mcg folic acid represents an amount commonly found in over-the-counter prenatal supplements. Women will be asked to take the supplements daily throughout the duration of gestation and to follow their standard prenatal diet, with the exception of avoiding highly fortified (> 100% RDA) ready-to-eat cereals and fortified energy/snack bars and drinks, due to their high folic acid content.
At the first visit, the participants will be instructed in the use of a dietary recall data collection sheet (food diary) which they will be asked to complete during specific time points during the study. Each set of dietary recalls will include information for three 24-hr periods on non-consecutive days including one weekend day. Dietary recall information will be obtained at approximately weeks 16 and 32 of gestation. This will permit assessment of typical dietary intake of total calories and specific nutrients, including folate.
Blood samples will be collected, in the non-fasting state, at the first, 28 week and 36 week prenatal visits and from the mother and cord blood at delivery for determination of primary outcome measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid, 400 mcg/day | Active comparator | Dietary Supplement: Folic acid, 400 mcg/dayA daily 400 microgram (mcg) dose of folic acid will be taken orally, along with the recommended intake for pregnancy of other vitamins, minerals and docosahexaenoic acid (DHA), beginning at enrollment until delivery. The 400 mcg dose approximates the current Recommended Dietary Allowance (RDA) for pregnant women of 600 mcg Dietary Folate Equivalents (400 mcg folic acid ≈ 600 mcg DFEs; conversion factor based on higher bioavailability of folic acid is: 1 mcg folic acid = 1.7 mcg DFE). |
| Folic acid, 800 mcg/day | Experimental | Dietary Supplement: Folic acid 800 mcg/dayA daily 800 microgram (mcg) dose of folic acid will be taken orally, along with the recommended intake for pregnancy of other vitamins, minerals and docosahexaenoic acid (DHA), beginning at enrollment until delivery. The 800 microgram dose, which is considerably higher than the current RDA, represents an amount commonly found in over-the-counter prenatal vitamin formulations. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy women with singleton pregnancy
- < 10 weeks gestation at enrollment
- body mass index 18.5 - 35.0 kg/m2
- willingness to comply with study protocol ( i.e. take assigned daily prenatal vitamin; complete diet recall and study questionnaire)
- not consuming super-fortified ready-to-eat cereal products (with > 100% RDA for folate per serving)
Key exclusion criteria (12 listed)
- BMI < 18.5 or > 35.0 kg/m2
- use of prescription drugs
- anemia
- chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease)
- acute illness (e.g. pneumonia, urinary tract infection, mononucleosis)
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 acid, 400 mcg/dayThe supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements). | Dietary supplement | Folic acid, 400 mcg/day |
| Folic acid 800 mcg/dayThe supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements) and 400 mcg folic acid. | Dietary supplement | Folic acid, 800 mcg/day |
Primary outcome
Serum folate
Time frame: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Change in serum folate concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus. Cord blood serum folate at delivery will also be determined by the microbiological assay. Differences in serum folate response to the two levels of folic acid supplementation will be compared.
Red blood cell (RBC) folate
Time frame: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Change in red blood cell (RBC) folate concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus. Cord blood RBC folate at delivery will also be determined by the microbiological assay. Differences in RBC folate response to the two levels of folic acid supplementation will be compared.
Serum folic acid
Time frame: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Change in serum folic acid concentrations in response to supplementation during pregnancy with one of two levels of folic acid will be determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cord blood serum folic acid at delivery will also be determined by LC-MS/MS. Differences in serum folic acid in response to the two levels of folic acid supplementation will be compared.
Gene-specific DNA methylation
Time frame: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Change in DNA methylation in response to folic acid supplementation during pregnancy will be determined in DNA isolated from whole blood. Illumina Infinium HumanMethylatio450 bead chip microarrays will be used to assess changes in multiple methylation sites of specific genes within regulatory pathways for folate metabolism and/or development. Differences in DNA methylation in response to the two levels of folic acid supplementation will be compared. We anticipate analyzing DNA methylation response at multiple time points and in all participants. Due to the expense associated with the analysis, however, we may be able to perform the analysis only at baseline and delivery and in only a subset of the participants if we are unable to secure additional funding.
5 secondary outcomes
Cell-type-specific DNA methylation
Time frame: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery
Infant birth weight
Time frame: Delivery
Infant length
Time frame: Delivery
Infant head circumference
Time frame: Delivery
Apgar score
Time frame: Delivery
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 5 Mar 2018.
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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.
Lynn B Bailey, PhD principal investigator
University of Georgia
Dorothy B Hausman, PhD study director
University of Georgia
Hea Jin Park, PhD study director
University of Georgia
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, 400 mcg/day and Folic acid 800 mcg/day in people with Pregnancy, run by University of Georgia at 1 site in United States.
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 12 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 5 Mar 2018. 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 United States. 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?
Serum folate (time frame: Baseline (Initial Prenatal Visit), 28 and 36 weeks gestation, delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2018.