Correspondence of Folate Dietary Intake and Biomarker Data | NCT03089684

Studies
Correspondence of Folate Dietary Intake and Biomarker Data

NCT03089684

Sponsor

National Institute of Health and Nutrition

Status

Completed

Last Update Posted

Mar 24, 2017Actual

Enrollment

4,878Actual

Phase

Not provided

Conditions

Folate Deficiency

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2012Actual

Completion Date

Dec 31, 2012Actual

First Submitted Date

Mar 14, 2017

First Submission Date that Met QC Criteria

Mar 23, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2017

Last Update Posted Date

Mar 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Regan Bailey, Nutritional Epidemiologist, National Institute of Health and NutritionPrincipal Investigator

Lead Sponsor

National Institute of Health and NutritionOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,878Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Folate status	Comparison of folate in diet and blood	Up to 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults, ages 19+ years

Exclusion Criteria:

missing data
non-pregnant
non-lactating

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Nov 2, 2017
Reset	Dec 1, 2017
Release	Jan 12, 2018
Reset	Nov 1, 2018

Submission Tracking

Estimated Results First Submitted Date

Nov 2, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 2, 2017			Dec 1, 2017
Jan 12, 2018

Condition Browse Module

MeSH Terms

ID	Term
D005494	Folic Acid Deficiency

Ancestor Terms

ID	Term
D014804	Vitamin B Deficiency
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition

Browse Leaves

Not provided

Browse Branches

Not provided