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