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

NCT01741077 | Completed

• 1 other identifier: 1000012134
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

pregnancy; folic acid supplementation; reproduction; folate

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Red blood cell folate concentrations - 5-methyltetrahydrofolate (5-methylTHF)

  At the point of participation (this is a single visit, single test study)

• Red blood cell concentrations - 5-formyltetrahydrofolate (5-formylTHF)

  At the point of participation (this is a single visit, single test study)

• Red blood cell folate concentrations - 5,10-Methenyltetrahydrofolate (5,10-methenylTHF)

  At the point of participation (this is a single visit, single test study)

Study Arms (4)

pregnant women

pregnant women taking 1 mg folic acid;

Dietary Supplement: folic acid

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

Interventions

folic acid DIETARY_SUPPLEMENT

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

pregnant women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women of reproductive age

You may qualify if:

• pregnant women-
• between 30 to 36 weeks gestation
• taking 1 mg folic acid in a multisupplement
• non-pregnant women-
• not pregnant
• taking either 0, 1 or 5 mg folic acid in a multisupplement

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Hartman BA, Fazili Z, Pfeiffer CM, O'Connor DL. Neither folic acid supplementation nor pregnancy affects the distribution of folate forms in the red blood cells of women. J Nutr. 2014 Sep;144(9):1364-9. doi: 10.3945/jn.113.189233. Epub 2014 Jul 2.

  PMID: 24991041 DERIVED

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Deborah L O'Connor, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 4, 2012
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: April 1, 2010
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

CA (1)