Folic Acid Supplementation in Women of Child Bearing Age

NCT ID: NCT01841658

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-06-30

Brief Summary

The objective of this study is to identify genes whose expression is potentially modifiable due to changes in folate intake and help delineate mechanisms accounting for the variability in individual response to folic acid supplementation. The study will be conducted in normal weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic acid.

It is hypothesized that (1) a change in folate status, induced by the supplementation, will influence the DNA methylation of specific genes and (2) the DNA methylation response to folic acid supplementation may differ between the normal weight and the obese women of childbearing age.

Detailed Description

This study will be conducted in two phases. An initial screening study will be performed to determine folate status, MTHFR677 genotype and body composition of potential participants of the intervention study. Both folate status and MTHFR677 genotype are known independent predictors of response to folic acid supplementation. Blood samples will be collected, after an overnight fast, for determination of serum folate concentration and for MTHFR677 genotyping. Body composition and 24-hr dietary recalls will also be conducted during the screening visit.

The second phase is an eight week supplementation trial with 800 mcg/day folic acid. Screened individuals determined to have a serum folate < 30 nmol/L (< 50th percentile of NHANES 1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion in the supplementation trial. Participants will be instructed to avoid dietary supplements, fortified ready-to-eat cereals, and other high folate content foods during intervention. Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8 weeks of supplementation for determination of primary (DNA methylation profile) and secondary (nutritional, metabolic and health status biomarkers) outcome measures.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Folic Acid Normal Weight

Folic acid, tablet, 800 mcg, daily, eight weeks. Normal Weight individuals, each will serve as her own control.

Group Type: EXPERIMENTAL

Folic acid

Intervention Type: DIETARY_SUPPLEMENT

Participants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count.

Folic acid Obese

Folic acid, tablet, 800 mcg, daily, eight weeks. Obese individuals, each will serve as her own control.

Group Type: EXPERIMENTAL

Folic acid

Intervention Type: DIETARY_SUPPLEMENT

Participants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count.

Interventions

Folic acid

Participants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Screening Phase:
• Female 18-40 yr
• Body Mass index 18.5 to 24.9 or > 30 kg/m2
• Intervention Study:
• Serum folate < 30 nmol/L
• MTHFR677CC or MTHFR677CT genotype

Exclusion Criteria

• Currently pregnant, pregnancy within past 12 months
• Greater than 2 previous pregnancies
• Use of prescription drugs other than oral contraceptives
• Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
• Acute illness (pneumonia, urinary tract infection, mononucleosis)
• Use of antibiotics in past 30 days
• Current smoker
• Use of dietary supplements including multivitamins in past 30 days
• Habitual consumption of fortified ready-to-eat cereals
• Significant weight change in past 12 months
• Typical alcohol consumption of 2 or more drinks per day
• INTERVENTION: all above plus serum folate > 30 nmol/L; MTHFR677TT genotype

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Lynn B. Bailey, PhD

Department Head and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynn B Bailey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Dorothy Hausman, PhD

Role: STUDY_DIRECTOR

University of Georgia

Locations

University of Georgia

Athens, Georgia, United States

Countries

United States

Other Identifiers

UGA_FASUPPLEMENT_EPIGEN

Identifier Type: -

Identifier Source: org_study_id