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CompletedNCT03089684Updated Mar 24, 2017

Correspondence of Folate Dietary Intake and Biomarker Data

An observational study in Folate Deficiency, sponsored by National Institute of Health and Nutrition. Completed. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by National Institute of Health and Nutrition · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
4,878
Ages
19 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Folate Deficiency

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Keywords

  • NHANES
  • Folate
  • Folic Acid
03

In context

Folic Acid Deficiency

32 studies on the registry are indexed under Folic Acid Deficiency; 3 are open to participants now.

This study's enrollment of 4,878 is above the median of 280 across 17 observational studies indexed under Folic Acid Deficiency.

Browse Folic Acid Deficiency studies →

Lead sponsor

National Institute of Health and Nutrition is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adults, ages 19+ years

Exclusion criteria

Exclusion Criteria:

  • missing data
  • non-pregnant
  • non-lactating
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
4,878 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Folate status

    Comparison of folate in diet and blood

    Time frame: Up to 24 months

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2011 to primary completion in Dec 2012, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2017
First posted
Mar 24, 2017
StartActual
Jan 1, 2011
Primary completionActual
Dec 31, 2012
CompletionActual
Dec 31, 2012
Last update
Mar 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03089684
Lead sponsor
National Institute of Health and Nutrition
Responsible party
Regan Bailey (Nutritional Epidemiologist, National Institute of Health and Nutrition) — Principal investigator
First posted
Mar 24, 2017
Start date
Jan 1, 2011
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012
Last update
Mar 24, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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