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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03364556
Other study ID # 1159415
Secondary ID
Status Completed
Phase N/A
First received November 27, 2017
Last updated December 5, 2017
Start date June 2016
Est. completion date November 2017

Study information

Verified date November 2017
Source George Mason University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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, including self-reported dietary and supplement intake from one day of 24-hour recalls, serologic indicators, and dual x-ray absorptiometry (DXA) scans were analyzed in adults (n=49) testing positive for celiac disease to the tissue transglutaminase endomysial antibody assay (tTG-EMA). Statistical analysis included multiple linear regression modelling controlled for age, sex, race/ethnicity, energy intake, and poverty income ratio.


Recruitment information / eligibility

Status Completed
Enrollment 13893
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
George Mason University

Outcome

Type Measure Description Time frame Safety issue
Primary Dietary Intake 24 hour recall 24 hours
Secondary Bone Mineral Density DXA Baseline
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