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Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age

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ClinicalTrials.gov Identifier: NCT01743196
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Lynn B. Bailey, PhD, University of Georgia

Brief Summary:
The purpose of this study is to determine if there is a difference in the short term response in serum folate after a single dose of folic acid in normal weight and obese women of childbearing age.

Condition or disease
Obesity Neural Tube Defects

Detailed Description:
Current recommendations established in 1998, specify that all women capable of becoming pregnant consume 400 micrograms of folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet. Despite this recommendation, obese women have a lower folate status than women of normal weight which suggests that obesity may have a negative impact on folate metabolism. Therefore, the objective of this study is to determine if there are differences in the metabolic response to a single dose of folate between normal weight and obese women of child bearing age. The two groups of women will be given the currently recommended amount of folic acid, 400 micrograms, and blood samples will be taken before the vitamin is given and at various points afterwards to determine serum folate response to the folate dose. Results of this research should help determine if folate requirements are higher for obese than for non-obese women. The long-term goal of this and follow-up studies is to generate data that will contribute to the evidence base used by scientific advisory panels to determine whether dietary folate intake recommendations should be based on body weight.

Study Type : Observational
Actual Enrollment : 32 participants
Official Title: Pilot Study of Folate Pharmacokinetics in Normal Weight and Obese Women of Child-bearing Age
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2014


Group/Cohort
Normal weight
Women with BMI 18.5 to 24.9 kg/m2
Obese
Women with BMI > 30 kg/m2



Primary Outcome Measures :
  1. Area under the serum concentration versus time curve (AUC) for folic acid [ Time Frame: 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 10.0 hours post-dose ]
    Change from baseline in serum folate response at the indicated time points following oral intake of a 400 ug dose of folic acid will be calculated by subtracting the baseline concentrations from the folate value at each subsequent time point. Individual response-time curves will be generated and area-under-the-curve (AUC) calculated using the trapezoidal rule.


Secondary Outcome Measures :
  1. Peak Serum Concentration (Cmax) of Folate [ Time Frame: up to 10 hours ]
    Maximum folate concentration in response to an oral dose of 400 ug folic acid. Values are derived from the individual response curves.

  2. Time to peak concentration (tmax) of folate [ Time Frame: up to 10 hours ]
    Time to peak serum concentration of folate following the oral administration of a 400 ug dose of folic acid. Values are derived from the individual response curves.


Biospecimen Retention:   Samples With DNA
Buffy Coat Serum samples Plasma samples


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample from Athens, GA and surrounding area
Criteria

Inclusion Criteria:

  • Female 18-35 yr
  • Caucasian
  • Body mass index 18.5 - 24.9 or > 30 kg/m2

Exclusion Criteria:

  • Currently pregnant, pregnancy within the past 12 months
  • Greater than 2 previous pregnancies
  • Use of prescription drugs other than oral contraceptives
  • Chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease)
  • Acute illness (e.g. pneumonia, urinary tract infection, mononucleosis)
  • Use of antibiotics in past 30 days
  • Current smoker
  • Use of dietary supplements including multivitamins in the past 30 days
  • Significant weight change in past 12 months
  • Typical alcohol consumption of 2 or more drinks per day
  • Consumption of any alcohol in the week preceding testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743196


Locations
United States, Georgia
University of Georgia
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
Principal Investigator: Lynn B Bailey, PhD University of Georgia

Publications of Results:
Responsible Party: Lynn B. Bailey, PhD, Department Head and Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT01743196     History of Changes
Other Study ID Numbers: UGAFOLATEPILOT
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by Lynn B. Bailey, PhD, University of Georgia:
Folic acid
Folate
Pharmacokinetics
Women of Child Bearing Age

Additional relevant MeSH terms:
Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs