Celiac Disease Clinical Trial
Official title:
Nutritional Intake and Bone Health Among Adults With Undiagnosed, Untreated Celiac Disease
Verified date | November 2017 |
Source | George Mason University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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George Mason University |
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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