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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743196
• Other study ID #: UGAFOLATEPILOT
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: October 20, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Neural Tube Defects
• Obesity
• Spinal Dysraphism

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No