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Nutritional Intake and Bone Health in Celiac Disease

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ClinicalTrials.gov Identifier: NCT03364556
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
George Mason University

November 27, 2017
December 6, 2017
December 6, 2017
June 2016
November 2017   (Final data collection date for primary outcome measure)
Dietary Intake [ Time Frame: 24 hours ]
24 hour recall
Same as current
No Changes Posted
Bone Mineral Density [ Time Frame: Baseline ]
DXA
Same as current
Not Provided
Not Provided
 
Nutritional Intake and Bone Health in Celiac Disease
Nutritional Intake and Bone Health Among Adults With Undiagnosed, Untreated Celiac Disease
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.

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.

Observational
Observational Model: Other
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
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.
Celiac Disease
Other: No intervention
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13893
Same as current
November 2017
November 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03364556
1159415
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: NHANES is publicly available data. No data sharing plan is needed.
George Mason University
George Mason University
Not Provided
Not Provided
George Mason University
November 2017