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

NCT01743196 | Completed

• 1 other identifier: UGAFOLATEPILOT
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Neural Tube Defects

Keywords

Folic acid; Folate; Pharmacokinetics; Women of Child Bearing Age

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Peak Serum Concentration (Cmax) of Folate

  up to 10 hours

• Time to peak concentration (tmax) of folate

  up to 10 hours

Study Arms (2)

Normal weight

Women with BMI 18.5 to 24.9 kg/m2

Obese

Women with BMI \> 30 kg/m2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample from Athens, GA and surrounding area

You may qualify if:

• Female 18-35 yr
• Caucasian
• Body mass index 18.5 - 24.9 or \> 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Related 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.

  PMID: 23567925 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buffy Coat Serum samples Plasma samples

MeSH Terms

Conditions

Obesity; Neural Tube Defects

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lynn B Bailey, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head and Professor

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2014
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)