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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lynn B. Bailey, PhD, University of Georgia
ClinicalTrials.gov Identifier:
NCT01743196
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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
Obesity
Neural Tube Defects

Study Type: Observational
Official Title: Pilot Study of Folate Pharmacokinetics in Normal Weight and Obese Women of Child-bearing Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Peak Serum Concentration (Cmax) of Folate [ Time Frame: up to 10 hours ] [ Designated as safety issue: No ]
    Maximum folate concentration in response to an oral dose of 400 ug folic acid. Values are derived from the individual response curves.

  • Time to peak concentration (tmax) of folate [ Time Frame: up to 10 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 32
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal weight
Women with BMI 18.5 to 24.9 kg/m2
Obese
Women with BMI > 30 kg/m2

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
Folic acid
Folate
Pharmacokinetics
Women of Child Bearing Age

Additional relevant MeSH terms:
Neural Tube Defects
Spinal Dysraphism
Obesity
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013