Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|