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

Primary Purpose

Obesity, Neural Tube Defects

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Obesity focused on measuring Folic acid, Folate, Pharmacokinetics, Women of Child Bearing Age

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Normal weight

Obese

Arm Description

Women with BMI 18.5 to 24.9 kg/m2

Women with BMI > 30 kg/m2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 4, 2012
Last Updated
October 20, 2015
Sponsor
University of Georgia
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1. Study Identification

Unique Protocol Identification Number
NCT01743196
Brief Title
Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age
Official Title
Pilot Study of Folate Pharmacokinetics in Normal Weight and Obese Women of Child-bearing Age
Study Type
Observational

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Neural Tube Defects
Keywords
Folic acid, Folate, Pharmacokinetics, Women of Child Bearing Age

7. Study Design

Enrollment
32 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
Buffy Coat Serum samples Plasma samples

8. Arms, Groups, and Interventions

Arm Title
Normal weight
Arm Description
Women with BMI 18.5 to 24.9 kg/m2
Arm Title
Obese
Arm Description
Women with BMI > 30 kg/m2
Primary Outcome Measure Information:
Title
Area under the serum concentration versus time curve (AUC) for folic acid
Description
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.
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
Secondary Outcome Measure Information:
Title
Peak Serum Concentration (Cmax) of Folate
Description
Maximum folate concentration in response to an oral dose of 400 ug folic acid. Values are derived from the individual response curves.
Time Frame
up to 10 hours
Title
Time to peak concentration (tmax) of folate
Description
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.
Time Frame
up to 10 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Study Population Description
Community sample from Athens, GA and surrounding area
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn B Bailey, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23567925
Citation
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.
Results Reference
result

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

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