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. Author manuscript; available in PMC: 2015 Dec 1.
Published in final edited form as: Blood Cells Mol Dis. 2014 Jul 25;53(4):221–230. doi: 10.1016/j.bcmd.2014.06.003

Table 1.

Study entry criteria

Inclusion criteria Exclusion criteria
  1. Age ≥ 65 years old

  2. Hemoglobin concentration ≥ 9.0 g/dL and < 11.5 g/dL for women and ≥ 9.0 to < 12.7 g/dL for men

  3. Unexplained anemia (see Table 2 for identifiable etiologies of anemia that investigator must review)

  4. Serum ferritin level ≥ 20 and ≤ 200 ng/mL

  5. Able to walk without the use of a walker or motorized device, or the assistance of another person

  6. Able to understand and be willing to provide written informed consent in the absence of dementia, defined as a Montreal Cognitive Assessment score ≥ 22

  7. Able to understand and speak in English, or at select sites where Spanish-speaking study staff and written informed consent in Spanish are available and approved by the institutional review board, Spanish- speaking subjects who do not speak English may be enrolled

  1. Red blood cell transfusions in the past 3 months

  2. Use of erythropoiesis stimulating agent in the past 3 months

  3. Intravenous iron infusions in the past 3 months

  4. Distance on baseline 6-minute walk test above age- and sex-adjusted population median

  5. History of unstable angina or myocardial infarction in the past 3 months

  6. History of stroke or transient ischemic attacks in the past 3 months

  7. Uncontrolled hypertension defined as greater than the average diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions on 2 separate days during screening

  8. Positive fecal occult blood test within the screening period

  9. Elevated aspartate aminotransferase or alanine aminotransferase ≥ 2× upper limit of normal

  10. Documented anaphylactic reaction to iron sucrose infusion in the past

  11. Initiated on oral iron supplementation within the last 6 weeks, or within the last 3 months and having had at least a 1 g/dL improvement in hemoglobin since starting oral iron supplementation