Folate DeficiencyNCT03089684
Correspondence of Folate Dietary Intake and Biomarker Data
An observational study of Folate Deficiency, run by National Institute of Health and Nutrition.
Trial summary
This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Folate Deficiency
- How many people
- 4,878 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2012
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.
Who may be able to join
- adults, ages 19+ years
Who cannot join
- missing data
- non-pregnant
- non-lactating
About this study
Official title: Correspondence of Dietary Intake and Biomarker Data
This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults.
Read the detailed description
Background: Public health concerns of both low and high folate status exist in the U.S. Recent publications have questioned the utility of self-reported dietary intake data in research and monitoring.
Objective: The purpose of this analysis was to examine the relationship between self-reported folate intakes and folate status biomarkers, and to evaluate their usefulness for several types of applications.
Design: Usual dietary intakes of folate were examined using the National Cancer Institute (NCI) method to adjust 2, 24-hour dietary recalls (including dietary supplements) for within-person variation and compared these intakes with serum and red blood cell (RBC) folate among 4,878 non-pregnant, non-lactating participants ≥19y in NHANES 2011-2012, a nationally representative, cross-sectional survey, with respect to consistency across prevalence estimates and rank order comparisons.
- Conditions
- Folate Deficiency
- Being tested
- No intervention
- Keywords
- NHANES, Folate, Folic Acid
- Medical subject headings
- Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Folate status
Comparison of folate in diet and blood
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jan 2011
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folate DeficiencyStudies 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
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 4,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Health and Nutrition
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Regan Bailey, National Institute of Health and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089684
- Sponsor's protocol ID
- ODS2015_1
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correspondence of Dietary Intake and Biomarker Data
- ClinicalTrials.gov ID
- NCT03089684
- Acronym / sponsor ID
- ODS2015_1
- Conditions
- Folate Deficiency
- Keywords
- NHANES, Folate, Folic Acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,878 participants (actual)
- Lead sponsor
- National Institute of Health and NutritionOther government
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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.
This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults.
Detailed description
Background: Public health concerns of both low and high folate status exist in the U.S. Recent publications have questioned the utility of self-reported dietary intake data in research and monitoring.
Objective: The purpose of this analysis was to examine the relationship between self-reported folate intakes and folate status biomarkers, and to evaluate their usefulness for several types of applications.
Design: Usual dietary intakes of folate were examined using the National Cancer Institute (NCI) method to adjust 2, 24-hour dietary recalls (including dietary supplements) for within-person variation and compared these intakes with serum and red blood cell (RBC) folate among 4,878 non-pregnant, non-lactating participants ≥19y in NHANES 2011-2012, a nationally representative, cross-sectional survey, with respect to consistency across prevalence estimates and rank order comparisons.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.
Key inclusion criteria (1 listed)
- adults, ages 19+ years
Key exclusion criteria (3 listed)
- missing data
- non-pregnant
- non-lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Folate status
Time frame: Up to 24 months
Comparison of folate in diet and blood
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 24 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Folate Deficiency, run by National Institute of Health and Nutrition.
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 1 inclusion and 3 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Folate status (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2017.