NCT03400436

Brief Summary

Dietary supplements are an important contributor to overall nutrient exposures for a large proportion of the U.S. population. Currently no standardized method exists to measure their use and contribution to total nutrient intakes, substantially limiting the rigor and reproducibility of their measurement. The purpose of this proposed project is to develop a standardized, data-driven, and valid metric that can be to measure use of and nutrient exposures from dietary supplements for use in research, clinical, and monitoring settings.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

3.9 years

First QC Date

November 2, 2017

Last Update Submit

January 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nutrient quality index

    This study will develop the nutrient quality index; this will be the tool used to measure nutrient quality in other studies.

    NHANES 2011 to 2014

Interventions

No intervention in observational studies

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The NHANES is a nationally representative, cross-sectional continuous survey that includes non-institutionalized, civilian U.S. residents using a complex, stratified, multistage probability cluster sampling design. The NHANES data are publicly available and are released in 2-year datasets to ensure confidentiality of the participants and to allow for adequate sample size for statistical analysis. The NHANES data are planned and collected by the National Center for Health Statistics of the Centers for Disease Control and Prevention. Written informed consent is obtained for all participants or proxies and the survey protocol is approved by the research ethics review board at the National Center for Health Statistics. Currently, we plan to use NHANES 2011-2012 and 2013-2014 data cycles because these are the first to include oversampling of non-Hispanic Asian Americans and have supplement intake data collected on both the 24HRs and the 30-day frequency questionnaire.

You may qualify if:

  • Children (\</=18 years) and adults (\>/=19 years) will be examined separately given the differential usage patterns in frequency and type of dietary supplements.

You may not qualify if:

  • Pregnant and lactating females will be excluded from analysis because they are more likely to use dietary supplements than the general population.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Jun S, Cowan AE, Dodd KW, Tooze JA, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Potischman N, Bhadra A, Forman MR, Bailey RL. Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016. Am J Clin Nutr. 2021 Sep 1;114(3):1059-1069. doi: 10.1093/ajcn/nqab113.

  • Cowan AE, Jun S, Tooze JA, Dodd KW, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Moshfegh AJ, Rhodes DG, Bhadra A, Bailey RL. Comparison of 4 Methods to Assess the Prevalence of Use and Estimates of Nutrient Intakes from Dietary Supplements among US Adults. J Nutr. 2020 Apr 1;150(4):884-893. doi: 10.1093/jn/nxz306.

  • Bailey RL, Dodd KW, Gahche JJ, Dwyer JT, Cowan AE, Jun S, Eicher-Miller HA, Guenther PM, Bhadra A, Thomas PR, Potischman N, Carroll RJ, Tooze JA. Best Practices for Dietary Supplement Assessment and Estimation of Total Usual Nutrient Intakes in Population-Level Research and Monitoring. J Nutr. 2019 Feb 1;149(2):181-197. doi: 10.1093/jn/nxy264.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2017

First Posted

January 17, 2018

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

NHANES data are publicly available