Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Positive results for Expanded Celiac Disease Panel
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Positive results for Expanded Celiac Disease Panel
时间窗: Upon consent and enrollment in the study, laboratory tests will be done to evaluate for the presence of Celiac Disease
Expanded Celiac Disease Panel includes TTG-IgG, TTG-IgA, AntiGliadin-IgG, AngtiGliadin-IgA, and Total Serum IgA
次要结局
- Percentage of Clinic Patient Population with one or more markers of iron deficiency(at enrollment)