Clinical Research Details

Descriptive Information
Randomized Cross-Over Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease

Ala Sharara


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 4  

  • Rani Shayto
Louma Rustam
Extension: 5909
Conditions and Keywords
inflammatory bowel disease,iron deficiency anemia
IBD,inflammatory bowel disease,iron deficiency anemia,captafer,iron sulfate
Study Design
Safety and/or Efficacy Study
Open Label
N/A: Not Applicable
Eligibility and IRB
Min: 18

This is an open label cross over study conducted at the American University of Beirut Medical Center aimed at comparing the efficacy and safety of Captafer versus Iron Sulfate in the treatment of iron deficiency anemia in patients suffering from Ulcerative colitis or Crohn's disease.

  1. Tolerability of Captafer and Iron Sulfate (primary objective)
  2. Response to iron repletion by measuring hemoglobin and hematocrit (secondary objective)
  3. Compliance and adherence to medication intake (secondary objective)

20 patients suffering from iron deficiency anemia as well as inflammatory bowel disease will be consecutively recruited from the outpatient clinics or the endoscopy unit of the American University of Beirut Medical Center.

Patients identified to have iron deficiency anemia on routine blood tests and who are suffering from Inflammatory Bowel Disease (IBD) will be consecutively recruited to participate in this study. Patients will be divided into two groups, 10 patients each, and will be started on either Captafer or Iron Sulfate therapy for a total of 6 weeks. Upon completion of the first course of therapy, patients will be required to stop medication for a 2 week washout period and will be crossed over to the other medication for an additional 6 weeks.

  1. Age 18 or older
  2. Confirmed diagnosis of Ulcerative Colitis or Crohn's disease
  3. Proven Iron deficiency anemia (Hb < 12, transferrin saturation <20%)
  4. Active left sided colitis or extensive disease (Mayo score ≥5 or Partial mayo score ≥4)
  5. Hemoglobin level ≥8 g/dL

  1. Age below 18
  2. Hemoglobin level ≤ 8 g/dL
  3. Recently hospitalized for disease flare (within 3 months)
  4. Hemoglobinopathies (including thalassemia)
  5. isolated proctitis
  6. indeterminate colitis
  7. known liver or kidney disease
  8. known celiac disease
  9. small bowel resection
  10. use of anticoagulants or aspirin
  11. known intolerance to oral therapy
  12. uninvestigated anemia
  13. pregnant or lactating women
  14. known hypersensitivity to iron sulfate
  15. transfusion within last 4 weeks
  16. erythropoetin within last 8 weeks
  17. Rheumatoid Arthritis
  18. history of menometrorrhagia or frequent epistaxis
  19. use of stomach acid-reducing products (classical antacids, PPIs, H2 Blockers)
  20. Gastritis