Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting

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