Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting
Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting
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:

 -  Prevalence of specific serum markers of celiac disease in those with unexplained serum
 markers of iron deficiency.

 -  Prevalence of iron malabsorption with and without celiac disease in the same population

 -  Frequency of other blood tests for malabsorption and their association with celiac
 disease or other cause of iron malabsorption.

 -  Frequency of specific historical markers associated with celiac disease

 -  Prevalence of unrecognized GI blood loss

 -  Quality of life improvement based on new diagnoses with appropriate therapy

 -  After one year follow-up, review patient records for additional diagnoses explaining
 iron deficiency.

 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:

 -  Define percent of total clinic patient population with one or more markers of iron
 deficiency on last testing and the subset without an apparent etiology on their problem
 list ("study group").

 -  Define percent of patients in the study group that are currently iron deficient at time
 of study onset, and how many of those are actually anemic.

 -  Define percent of study group patients with iron malabsorption, with or without celiac
 disease.

 -  Document improved quality of life outcomes for those with new diagnoses and appropriate
 therapy, including celiac disease given gluten-free diet and iron therapy.

 -  For those patients identified with celiac disease, do statistical analysis of historical
 and lab parameters that are more highly linked to celiac disease to improve screening
 parameters.

 -  Document percent of various diagnoses that explain occult iron deficiency as found by
 primary care providers over the course of a one year follow-up after initial diagnosis.
 (Providers will be given all testing results related to their patients after the initial
 screening and at one year.)

 -  Specific cost-effectiveness of this screening procedure may be done in a future study if
 preliminary results are suggestive of improved outcomes.
Inclusion Criteria:

 1. Active outpatients in the Providence Internal Medicine Residency Clinic, Family
 Medicine Residency Clinics, or Providence Internal Medicine Clinic

 2. Demographic Age > 18 years. Diagnostic criteria: markers of iron deficiency at last
 check are defined as MCV<80 fL, Iron Sat<20% or ferritin<30 ng/mL.

 3. Patient signs informed consent document and HIPAA authorization for release of
 personal health information.

 4. Ability to understand procedures and comply with them for one year duration of study

 Exclusion Criteria:

 1. Any documented significant acute or chronic blood loss, per medical record review or
 self- report (see Appendix B). Significant blood loss includes

 1. Acute blood loss requiring iron treatment or transfusions within 1 year prior to
 the above measure of iron deficiency

 2. Chronic blood loss (such as menorrhagia, GI bleeding, hemoptysis, hematuria,
 chronic nose bleeds, hemolysis, regular blood donations, or major trauma
 requiring transfusion or iron therapy)

 3. Thalassemia or other major hemolytic diseases.

 2. Prior diagnosis of celiac disease, or other documented cause of iron malabsorption.

 3. Women who are currently pregnant, or who were pregnant with 6 months prior to time of
 last testing.

 4. Those currently or recently on chemotherapy (within the last 6 months)

 5. Those with prior gastric resection or bariatric surgery

 6. Those with advanced chronic kidney disease (stage 4 or 5)

 7. Any other reasons that, in the investigators' opinion, may prevent compliance with
 protocol