Mechanisms Accounting for Unexplained Anemia in the Elderly

• INCLUSION CRITERIA:

• Ambulatory, community dweller

• Age greater than or equal to 70 years or older or between the ages of 18 and 50years.

• Able to understand English

• Able to complete study questionnaires as determined by the investigator

• Evidence for recent (within 1 year) clinical evaluation for blood loss directed byprimary care physician or consultant in subjects referred with microcytic anemia orwith referring laboratories indicative of iron deficiency. Furthermore, subjectsfound to have microcytic anemia will be eligible but will be referred to theirprimary doctor for evaluation of blood loss.

• Provide informed consent

EXCLUSION CRITERIA:

• Hemoglobin (Hb) less than 9 g/dL during screening

• History of red blood cell transfusion withinthe 3 month period prior to accrual tothis study, or evidence for active bleeding as ascertained by medical history (e.g.,persistent melena, hematuria or dysfunctional uterine bleeding).

• Patients for whom oral iron supplementation has been prescribed within the past twomonths. (Patients on a stable dose of oral iron for more than two months may beeligible).

• ALT or AST more than 3 times upper normal limitation of the time of screening

• B12 or folate deficiencies during screening period

• Estimated GFR less than 30 ml/min/1.73m(2)during screening period (by the 4-variableModification of Diet in Renal Disease [MDRD] equation).

• Receiving hemodialysis or peritoneal dialysis for renal failure, or history ofkidney transplant

• Use of exogenous erythropoietin during the past 3 months

• Any major surgery requiring general anesthesia within the past 3 months

• Treatment with chemotherapy or radiotherapy in the past 12 months

• Current diagnosis of active cancer, other than non-melanoma skin cancer and, stableprostate cancer

• History of blood disorders including thalassemia, sickle cell disease ormyelodysplasia

• Current severe (NYHA Class III - IV) congestive heart failure or advanced chronicobstructive pulmonary disease

• Positive serum monoclonal protein and immunofixation

• Women who are pregnant or women planning to get pregnant during the duration of thestudy or those with a positive pregnancy test during screening

• Active infection requiring antibiotic treatment or HIV, Hepatitis B or C

• History of overt chronic inflammation, active Crohn s disease, rheumatoid arthritis,or diabetes(HbA1C greater than 7),

• Known hemolytic anemia

• History of prosthetic heart valve

• History of participation in biotinylation studies or handling biotinylated reagentproducts.