ObesityNCT01743196
Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age
An observational study of Obesity and Neural Tube Defects, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Neural Tube Defects
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample from Athens, GA and surrounding area
Who may be able to join
- Female 18-35 yr
- Caucasian
- Body mass index 18.5 - 24.9 or > 30 kg/m2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Folate Pharmacokinetics in Normal Weight and Obese Women of Child-bearing Age
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.
Read the 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.
- Conditions
- Obesity, Neural Tube Defects
- Keywords
- Folic acid, Folate, Pharmacokinetics, Women of Child Bearing Age
- Medical subject headings
- Obesity, Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Women with BMI 18.5 to 24.9 kg/m2 | |
| Obese | Women with BMI > 30 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Maximum folate concentration in response to an oral dose of 400 ug folic acid. Values are derived from the individual response curves.
Measured: up to 10 hours
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.
Measured: up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn B. Bailey, PhD, University of Georgia
- Investigators
- Lynn B Bailey, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743196
- Sponsor's protocol ID
- UGAFOLATEPILOT
- Status last verified
- Oct 2015
- First submitted
- 4 Dec 2012
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23567925
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Folate Pharmacokinetics in Normal Weight and Obese Women of Child-bearing Age
- ClinicalTrials.gov ID
- NCT01743196
- Acronym / sponsor ID
- UGAFOLATEPILOT
- Conditions
- Obesity, Neural Tube Defects
- Keywords
- Folic acid, Folate, Pharmacokinetics, Women of Child Bearing Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | –Women with BMI 18.5 to 24.9 kg/m2 |
| Obese | – | –Women with BMI > 30 kg/m2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample from Athens, GA and surrounding area
Key inclusion criteria (3 listed)
- Female 18-35 yr
- Caucasian
- Body mass index 18.5 - 24.9 or > 30 kg/m2
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Peak Serum Concentration (Cmax) of Folate
Time frame: up to 10 hours
Time to peak concentration (tmax) of folate
Time frame: up to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Results publication: PubMed 23567925da 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn B Bailey, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Neural Tube Defects, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.