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OpenTrials
Completed

NCT Number: NCT03364556

Nutritional Intake and Bone Health in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Dietary Intake

    Time frame: 24 hours

    24 hour recall

Secondary outcomes

  1. Bone Mineral Density

    Time frame: Baseline

    DXA

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Registry information

Official study title

Nutritional Intake and Bone Health Among Adults With Undiagnosed, Untreated Celiac Disease

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2017
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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