Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting

NCT02036944 | Terminated

• 1 other identifier: PMRC-1909-1
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Celiac Disease; Iron Deficiency; Iron Malabsorption

Keywords

Celiac Disease; Celiac Sprue; Iron-Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percentage of Clinic Patient Population with one or more markers of iron deficiency

  at enrollment

Other Outcomes (1)

• 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)

  Enrollment and End of One Year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from Providence Internal Medicine Clinic, Providence Internal Medicine Residency Services and Providence Family Medicine Residency Services

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

Sponsors & Collaborators

• Providence Medical Research Center: lead
• Providence Sacred Heart Medical Center & Children's Hospital: collaborator

Study Sites (1)

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Celiac Disease; Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Samuel Palpant, MD

  Providence Internal Medicine Residency Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)