Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 4, 2012
First Posted Date December 6, 2012
Last Update Posted Date October 21, 2015
Study Start Date May 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2012)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buffy Coat Serum samples Plasma samples
Sampling Method Non-Probability Sample
Study Population Community sample from Athens, GA and surrounding area
Condition
  • Obesity
  • Neural Tube Defects
Intervention Not Provided
Study Groups/Cohorts
  • Normal weight
    Women with BMI 18.5 to 24.9 kg/m2
  • Obese
    Women with BMI > 30 kg/m2
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2012)
32
Original Actual Enrollment Same as current
Actual Study Completion Date December 2014
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01743196
Other Study ID Numbers UGAFOLATEPILOT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lynn B. Bailey, PhD, University of Georgia
Study Sponsor University of Georgia
Collaborators Not Provided
Investigators
Principal Investigator: Lynn B Bailey, PhD University of Georgia
PRS Account University of Georgia
Verification Date October 2015