Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting

Stopped early

Conditions studied: Celiac Disease, Iron Deficiency, Iron Malabsorption

In brief

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.

Key facts

Study ID

NCT02036944

Run by

Providence Medical Research Center

People needed

13

Starts

2014-03-01

Expected to finish

2015-01-01

Last updated by the study team

2016-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Active outpatients in the Providence Internal Medicine Residency Clinic, Family Medicine Residency Clinics, or Providence Internal Medicine Clinic
• 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.
• Patient signs informed consent document and HIPAA authorization for release of personal health information.
• Ability to understand procedures and comply with them for one year duration of study

You may not qualify if…

• Any documented significant acute or chronic blood loss, per medical record review or self- report (see Appendix B). Significant blood loss includes
• Acute blood loss requiring iron treatment or transfusions within 1 year prior to the above measure of iron deficiency
• 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)
• Thalassemia or other major hemolytic diseases.
• 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

Where it is running

• Providence Medical Research Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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