NCT03364556

Brief Summary

Celiac disease leads to malnutrition and secondary conditions including osteoporosis. The dietary habits of adults with untreated, undiagnosed celiac disease has not yet been observed, but presents a critical piece in understanding the effects of the disease on bone health. Objective was to evaluate differences in nutritional intake of calcium, vitamin D, and phosphorus; serologic indices of these nutrients; and bone health among adults with and without celiac disease. Cross-sectional data from What We Eat in America (WWEIA) and the National Health and Nutrition Examination Survey (NHANES) 2009-14 was analyzed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13,893

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

November 27, 2017

Last Update Submit

December 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dietary Intake

    24 hour recall

    24 hours

Secondary Outcomes (1)

  • Bone Mineral Density

    Baseline

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged 18+ years with a complete 24-hour recall in WWEIA and a completed celiac disease serologic test. Two groups were used in the analysis. The control group consisted of a normal adult population without celiac disease, as indicated by a negative serologic test for celiac disease and no self-reported celiac disease. The serologically positive group were considered to have undiagnosed, untreated celiac disease based on a positive serologic test for celiac disease (EMA+), no self-reported celiac disease, and no adherence to a gluten-free diet. NHANES employs two steps of serologic tests for selected participants to screen for celiac disease antibodies that develop as a T-cell-mediated response to gluten.

You may qualify if:

  • Adults aged 18+ years with a complete 24-hour recall in WWEIA and a completed celiac disease serologic test. Two groups were used in the analysis. The control group consisted of a normal adult population without celiac disease, as indicated by a negative serologic test for celiac disease and no self-reported celiac disease. The serologically positive group were considered to have undiagnosed, untreated celiac disease based on a positive serologic test for celiac disease (EMA+), no self-reported celiac disease, and no adherence to a gluten-free diet. NHANES employs two steps of serologic tests for selected participants to screen for celiac disease antibodies that develop as a T-cell-mediated response to gluten.

You may not qualify if:

  • Adults were excluded if they were pregnant or breastfeeding at the time of the study, or if they reported any history of celiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 6, 2017

Study Start

June 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

December 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

NHANES is publicly available data. No data sharing plan is needed.