The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells

December 3, 2013 updated by: Brenda Hartman, The Hospital for Sick Children
The purpose of this cross-sectional study was to examine whether or not physical changes or adaptations occur in response pregnancy or to the higher intakes of folic acid from supplementation typically consumed during the reproductive period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Higher folate requirements during pregnancy to support growth and development are well established but it is unknown what metabolic changes occur in 1-carbon metabolism to provide sufficient nucleotides for DNA/RNA synthesis. Periconceptual folic acid (FA) supplementation and fortification of the food supply have been shown to reduce the risk of pregnancies with neural tube defects but conversely expose women to high FA intakes for extended periods of time. The purpose of this cross-sectional study is to establish if physiological adaptations occur in folate metabolism in response to pregnancy or higher intakes of FA typically consumed among women during the reproductive period. A convenience sample of thirty-two women (n=8/group) were recruited to compare the total concentrations and forms of folate (tetrahydrofolate [THF], 5-methylTHF, 5-formylTHF and 5, 10-methenylTHF) in red blood cells in four groups: a) pregnant women (PW, 30-36 weeks gestation) taking 1.0 mg of FA b) non-pregnant women (NPW) taking 0 mg of FA c) NPW taking 1.0 mg FA and d) NPW taking 5.0 mg FA. Blood samples were taken at a single time point and compared across groups. Total red blood cell concentrations were measured using both microbiological assay and liquid chromatography/tandem mass spectrometry (LC/MS/MS) analysis. LC/MS/MS analysis was used to determine folate form concentrations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women of reproductive age

Description

Inclusion Criteria:

  1. pregnant women-

    • between 30 to 36 weeks gestation
    • taking 1 mg folic acid in a multisupplement

  2. non-pregnant women-

    • not pregnant
    • taking either 0, 1 or 5 mg folic acid in a multisupplement

Exclusion Criteria:

  • Taking any medications known to interfere with folate absorption at the time of sampling (ie. Antibiotics [ can be enrolled into study if they will be off them at least two weeks prior to study commencement], methotrexate, aminopterin)
  • Those with a history of any disorders or conditions that could interfere with folate absorption or metabolism from either dietary or supplement sources such as the history/presence clinically significant gastrointestinal disease (chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved GI symptoms(diarrhea/vomiting), steatorrhea or other conditions that interfere with absorption, distribution, metabolism or excretion of folic acid.
  • Those with preexisting conditions (pre-existing maternal diabetes; insulin-dependent diabetes; previous child with neural tube disorder (NTD), cleft-lip/palate or heart defect; epilepsy and/or seizure disorders) that can increase the risk of pregnancy complicated by NTD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
pregnant women
pregnant women taking 1 mg folic acid;
Dietary supplement: folic acid
subjects take multivitamin supplement containing folic acid. Women were enrolled based on whether or not they were taking supplements.
non-pregnant women
non-pregnant women taking 0mg folic acid;
non-pregnant women 2
non-pregnant women taking 1 mg folic acid
non-pregnant women 3
non-pregnant women taking 5 mg folic acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Red blood cell folate concentrations - tetrahydrofolate (THF)
Time Frame: At the point of participation (this is a single visit, single test study)
Bood samples were taken once at the point of participation and compared 1) pregnant women (between 30-36 weeks gestation) and non-pregnant women who were taking supplements 2) 0 mg folic acid 3) 1 mg FA, 4) and 5 mg FA. Those who were taking supplements were taking them for a minimum of 30 weeks.
At the point of participation (this is a single visit, single test study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Red blood cell folate concentrations - 5-methyltetrahydrofolate (5-methylTHF)
Time Frame: At the point of participation (this is a single visit, single test study)
At the point of participation (this is a single visit, single test study)
Red blood cell concentrations - 5-formyltetrahydrofolate (5-formylTHF)
Time Frame: At the point of participation (this is a single visit, single test study)
At the point of participation (this is a single visit, single test study)
Red blood cell folate concentrations - 5,10-Methenyltetrahydrofolate (5,10-methenylTHF)
Time Frame: At the point of participation (this is a single visit, single test study)
At the point of participation (this is a single visit, single test study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deborah L O'Connor, PhD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000012134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on folic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings