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Study stopped d/t lack of enrollment and no compelling data.
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| Name | Class |
|---|---|
| Providence Sacred Heart Medical Center & Children's Hospital | OTHER |
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The purpose of this study is to determine if patients with unexplained iron deficiency have underlying diseases processes such as celiac disease.
It is hypothesized that selectively screening patients with unexplained iron deficiency will reveal previously undiagnosed etiologies, including celiac disease and other causes of iron malabsorption along with various sources of occult GI blood loss.
The primary purpose of the study is to document unexplained iron deficiency and its relationship to celiac disease, iron malabsorption and occult intestinal blood loss. Test results given to primary care physicians may prompt further testing for celiac disease (duodenal biopsy) or other potential causes of occult iron deficiency. The specific endpoints to be evaluated include:
Primary Objective:
Discover several etiologies of unexplained iron deficiency in a primary care clinic population including celiac disease, iron malabsorption and occult intestinal blood loss.
Secondary Objectives:
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| Measure | Description | Time Frame |
|---|---|---|
| Positive results for Expanded Celiac Disease Panel | Expanded Celiac Disease Panel includes TTG-IgG, TTG-IgA, AntiGliadin-IgG, AngtiGliadin-IgA, and Total Serum IgA | Upon consent and enrollment in the study, laboratory tests will be done to evaluate for the presence of Celiac Disease |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Clinic Patient Population with one or more markers of iron deficiency | Other tests will be done at enrollment to assess for iron malabsorption and possibly to identify causes of iron malabsorption other than celiac disease. These include Iron absorption Testing (serum iron level before and after oral FeSO4 tablet or liquid), with percent iron saturation. Ferritin, Hemoglobin and Hematocrit, Vitamin D level, Folate, Vitamin B12 level, Aspartate Aminotransferase (AST), and Stool Occult Blood Test |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Quality of Life after one year of intervention (either gluten-free diet if Celiac disease is diagnosed and/or recommendation of daily iron supplementation) | For patients diagnosed with Celiac disease at enrollment, a gluten-free diet will be advised explained by a Registered Dietician. Patients not diagnosed with celiac disease but with iron deficiency or malabsorption will be advised to take daily oral iron supplements. Quality of Life Surveys will be administered at enrollment and at the end of one year to assess for improvement resulting from diet and/or supplementation. |
Inclusion Criteria:
Exclusion Criteria:
Any documented significant acute or chronic blood loss, per medical record review or self- report (see Appendix B). Significant blood loss includes
Prior diagnosis of celiac disease, or other documented cause of iron malabsorption.
Women who are currently pregnant, or who were pregnant with 6 months prior to time of last testing.
Those currently or recently on chemotherapy (within the last 6 months)
Those with prior gastric resection or bariatric surgery
Those with advanced chronic kidney disease (stage 4 or 5)
Any other reasons that, in the investigators' opinion, may prevent compliance with protocol
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Patients from Providence Internal Medicine Clinic, Providence Internal Medicine Residency Services and Providence Family Medicine Residency Services
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Palpant, MD | Providence Internal Medicine Residency Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Medical Research Center | Spokane | Washington | 99204 | United States |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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The serum remaining from 10 mL of blood will be aliquoted and frozen at -70 degrees. If future funding allows, these samples will be tested for autoimmune and malabsorption markers.
| at enrollment |
| Enrollment and End of One Year |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019189 | Iron Metabolism Disorders |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |