Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients With IBD

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical feature of IBD. It is encountered in one third of IBD patients, and is the most common extraintestinal complication of this disease. Anemia has a significant impact on the quality of life of affected patients. Many patients with IBD frequently complain of chronic fatigue commonly caused by anemia and this may be as debilitating to patients as abdominal pain and diarrhea. Anemia in IBD is multifactorial, but is most commonly the result of iron deficiency anemia (IDA) and rarely due to anemia of chronic disease (ACD). Oral iron supplementation has been used traditionally for the treatment of IDA but studies have shown that it may result in disease exacerbation by increasing oxygen free radicals within the lumen of the gut via the Fenton reaction. A recent study done in University Hospitals Birmingham, United Kingdom, has shown that treatment with oral iron results in failure to control anemia in 2 out of 3 IBD patients, which is in part due to the side effects reported by over half of patients. Captafer is a new iron-free oral preparation that contains a special type of oligosaccharides from fish muscle tissue able to make the intestine absorb 3 to 5 times more iron in comparison to the "meat factor". Moreover, Captafer contains other vitamins and supplements that improve anemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Iron

Criteria

Inclusion Criteria:

• Age above 18

• Confirmed diagnosis of ulcerative colitis or Crohn's disease

• Proven iron deficiency anemia (Hb<12, transferrin saturation <20%)

• Active left sided colitis or extensive disease (Mayo Score≥5 or Partial Mayo score ≥4)

• Hemoglobin level > 8 g/dL

Exclusion Criteria:

• Age below 18

• Hemoglobin level < 8 g/dL

• Recently hospitalized for disease flare (within 3 months)

• Hemoglobinopathies (including thalassemia)

• Isolated proctitis

• indeterminate colitis

• Known Liver or kidney disease

• Known Celiac disease

• Small bowel resection

• Use of anticoagulants or aspirin

• Known intolerance to oral iron therapy

• Uninvestigated anemia

• Pregnant or lactating women

• Known hypersensitivity to iron sulfate

• Transfusion within the last 4 weeks

• Erythropoetin within the last 8 weeks

• Rheumatoid Arthritis

• History of menometrorrhagia or frequent epistaxis

• Use of Stomach acid-reducing product (classical antacids, Proton Pump Inhibitors, H2-receptors Inhibitors)

• Gastritis