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

Pilot Study of Folate Pharmacokinetics in Normal Weight and Obese Women of Child-bearing Age

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Community sample from Athens, GA and surrounding area

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the serum concentration versus time curve (AUC) for folic acid	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Serum Concentration (Cmax) of Folate	Maximum folate concentration in response to an oral dose of 400 ug folic acid. Values are derived from the individual response curves.	up to 10 hours
Time to peak concentration (tmax) of folate	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.	up to 10 hours

Collaborators and Investigators

• Sponsor: University of Georgia
• Investigators: Principal Investigator: Lynn B Bailey, PhD, University of Georgia

Publications and helpful links

General Publications

• da Silva VR, Hausman DB, Kauwell GP, Sokolow A, Tackett RL, Rathbun SL, Bailey LB. Obesity affects short-term folate pharmacokinetics in women of childbearing age. Int J Obes (Lond). 2013 Dec;37(12):1608-10. doi: 10.1038/ijo.2013.41. Epub 2013 Apr 9.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Folic acid; Folate; Women of Child Bearing Age
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: UGAFOLATEPILOT