Folic Acid Supplementation in Women of Child Bearing Age
FASUPP
Effect of Obesity and Folic Acid Supplementation on Gene-specific DNA Methylation in Women of Reproductive Age
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Apr 2013
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 4, 2016
July 1, 2016
2.3 years
April 19, 2013
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cell-type-specific DNA methylation
Change in DNA methylation in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined in DNA isolated from specific white blood cell types. Microarray analysis will be used to assess changes in multiple methylation sites within regulatory pathways for folate metabolism and/or development. Each subject will serve as her own control.
Baseline, 4 weeks and 8 weeks
Gene-specific DNA methylation
Change in DNA methylation in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined in DNA isolated from whole blood . Microarray analysis will be used to assess changes in multiple methylation sites of specific genes within regulatory pathways for folate metabolism and/or development. Each subject will serve as her own control.
Baseline, 4 weeks and 8 weeks
Secondary Outcomes (3)
Serum folate
Baseline, 4 weeks and 8 weeks
Red Blood Cell (RBC) Folate
Baseline, 4 weeks and 8 weeks
Body Composition
Baseline and 8 weeks
Study Arms (2)
Folic Acid Normal Weight
EXPERIMENTALFolic acid, tablet, 800 mcg, daily, eight weeks. Normal Weight individuals, each will serve as her own control.
Folic acid Obese
EXPERIMENTALFolic acid, tablet, 800 mcg, daily, eight weeks. Obese individuals, each will serve as her own control.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Georgialead
- University of Floridacollaborator
- Emory Universitycollaborator
Study Sites (1)
University of Georgia
Athens, Georgia, 30602, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn B Bailey, PhD
University of Georgia
- STUDY DIRECTOR
Dorothy Hausman, PhD
University of Georgia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Head and Professor
Study Record Dates
First Submitted
April 19, 2013
First Posted
April 26, 2013
Study Start
April 1, 2013
Primary Completion
August 1, 2015
Study Completion
June 1, 2016
Last Updated
July 4, 2016
Record last verified: 2016-07