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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741077
• Other study ID #: 1000012134
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: December 3, 2013
• Start date: May 2008
• Est. completion date: April 2010

Study information

• Verified date: December 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• folic acid
subjects take multivitamin supplement containing folic acid. Women were enrolled based on whether or not they were taking supplements.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell folate concentrations - tetrahydrofolate (THF)	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)	No
Secondary	Red blood cell folate concentrations - 5-methyltetrahydrofolate (5-methylTHF)		At the point of participation (this is a single visit, single test study)	No
Secondary	Red blood cell concentrations - 5-formyltetrahydrofolate (5-formylTHF)		At the point of participation (this is a single visit, single test study)	No
Secondary	Red blood cell folate concentrations - 5,10-Methenyltetrahydrofolate (5,10-methenylTHF)		At the point of participation (this is a single visit, single test study)	No