Status:
COMPLETED
Folic Acid Supplementation in Women of Child Bearing Age
Lead Sponsor:
University of Georgia
Collaborating Sponsors:
University of Florida
Emory University
Conditions:
Obesity
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 r...
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 interventio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01841658
Start Date
April 1 2013
End Date
June 1 2016
Last Update
July 4 2016
Active Locations (1)
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1
University of Georgia
Athens, Georgia, United States, 30602