Correspondence of Folate Dietary Intake and Biomarker Data

Folate Deficiency Clinical Trial

Official title:

Correspondence of Dietary Intake and Biomarker Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089684
• Other study ID #: ODS2015_1
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 23, 2017
• Start date: January 1, 2011
• Est. completion date: December 31, 2012

Study information

• Verified date: March 2017
• Source: National Institute of Health and Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4878
• Est. completion date: December 31, 2012
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• adults, ages 19+ years

Exclusion Criteria:

• missing data

• non-pregnant

• non-lactating

Related Conditions & MeSH terms

• Folate Deficiency
• Folic Acid Deficiency

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Health and Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Folate status	Comparison of folate in diet and blood	Up to 24 months