Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age
|ClinicalTrials.gov Identifier: NCT01743196|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : October 21, 2015
|Condition or disease|
|Obesity Neural Tube Defects|
|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|
Women with BMI 18.5 to 24.9 kg/m2
Women with BMI > 30 kg/m2
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743196
|United States, Georgia|
|University of Georgia|
|Athens, Georgia, United States, 30602|
|Principal Investigator:||Lynn B Bailey, PhD||University of Georgia|