Trial record 2 of 142 for:    folic acid AND pregnancy NOT (male OR men)

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brenda Hartman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01741077
First received: November 27, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Pregnancy
Dietary Supplement: folic acid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Red blood cell folate concentrations - tetrahydrofolate (THF) [ Time Frame: At the point of participation (this is a single visit, single test study) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Red blood cell folate concentrations - 5-methyltetrahydrofolate (5-methylTHF) [ Time Frame: At the point of participation (this is a single visit, single test study) ] [ Designated as safety issue: No ]
  • Red blood cell concentrations - 5-formyltetrahydrofolate (5-formylTHF) [ Time Frame: At the point of participation (this is a single visit, single test study) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women of reproductive age

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741077

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Deborah L O'Connor, PhD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Brenda Hartman, Clinical Dietitian, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01741077     History of Changes
Other Study ID Numbers: 1000012134
Study First Received: November 27, 2012
Last Updated: December 3, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pregnancy
folic acid supplementation
reproduction
folate

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014