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

NCT ID: NCT02774057

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-08-31

Brief 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.

Detailed Description

Twenty patients from the outpatient department at AUBMC will be enrolled in this open label cross-over trial. Patients with active left sided ulcerative colitis, Crohn's disease or active extensive disease with proven IDA will be enrolled. Study patients will receive the treatment following informed consent and will be followed up regularly by the study coordinator for side effects, compliance and adherence. A blood test for hemoglobin and hematocrit and other biomarkers of iron stores and repletion will be done on all patients at baseline and then after 6 weeks and 12 weeks of therapy. In case patients did not tolerate either treatment, they will be switched to the other treatment after a washout period of 2 weeks.

The objective of this study is to compare the efficacy and safety of Captafer which is an iron-free (one fixed non disclosed dose) food supplement given twice daily, to oral iron therapy given at a dose of 195 mg twice daily for the same period of time in an open label cross-over trial in the treatment of iron deficiency anemia in ulcerative colitis and Crohn's disease patients.

Primary endpoint:

Tolerability

Secondary endpoints

Response to iron repletion as using hemoglobin and hematocrit as surrogates Compliance and adherence (monthly pill count)

The study sample size was calculated based on the primary end points of tolerability with a significance level (α) of 0.05, a Power (1-β) of 0.8 with an expected 90% tolerability and adherence for Captafer vs. 50% for oral iron. At these parameters, and taking a non-inferiority limit of 5%, the sample size was calculated to be 20.

Conditions

Iron Deficiency Anemia; Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Initial therapy with Captafer®

This arm will consist of 10 patients who will begin Captafer® therapy twice daily for 6 weeks, then undergo a 2 week washout period before crossing over to Iron Sulfate therapy twice daily for an additional 6 weeks.

Group Type: EXPERIMENTAL

Captafer®

Intervention Type: DRUG

2 pills daily. Contains

• Vitamin C, known for its property to facilitate iron absorption by reducing iron to the reduced ferrous state necessary for uptake;
• Vitamin E, an antioxidant, along with vitamin C it protects Fe++;
• Folic acid, necessary to prevent megaloblastic anemia and abnormalities in the fetal nervous system, vital during pregnancy;
• Zinc and Copper which act in different mitochondrial cytochromes-dependent systems and contribute to the use of iron by the biological systems

Iron Sulfate

Intervention Type: DRUG

195 mg Iron supplement

Initial therapy with Iron Sulfate

This arm will consist of 10 patients who will begin Iron Sulfate therapy twice daily for 6 weeks, then undergo a 2 week washout period before crossing over to Captafer® therapy twice daily for an additional 6 weeks.

Group Type: EXPERIMENTAL

Captafer®

Intervention Type: DRUG

2 pills daily. Contains

• Vitamin C, known for its property to facilitate iron absorption by reducing iron to the reduced ferrous state necessary for uptake;
• Vitamin E, an antioxidant, along with vitamin C it protects Fe++;
• Folic acid, necessary to prevent megaloblastic anemia and abnormalities in the fetal nervous system, vital during pregnancy;
• Zinc and Copper which act in different mitochondrial cytochromes-dependent systems and contribute to the use of iron by the biological systems

Iron Sulfate

Intervention Type: DRUG

195 mg Iron supplement

Interventions

Captafer®

2 pills daily. Contains

• Vitamin C, known for its property to facilitate iron absorption by reducing iron to the reduced ferrous state necessary for uptake;
• Vitamin E, an antioxidant, along with vitamin C it protects Fe++;
• Folic acid, necessary to prevent megaloblastic anemia and abnormalities in the fetal nervous system, vital during pregnancy;
• Zinc and Copper which act in different mitochondrial cytochromes-dependent systems and contribute to the use of iron by the biological systems

Intervention Type: DRUG

Iron Sulfate

195 mg Iron supplement

Intervention Type: DRUG

Other Intervention Names

Ironorm

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ala'a Sharara

Professor, Head of Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

American University of Beirut - Medical Center

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Ala I Sharara, MD

Role: CONTACT

as08@aub.edu.lb

01350000 ext. 4765

Facility Contacts

Ala' I. Sharara, MD

Role: primary

as08@aub.edu.lb

009611350000 ext. 5345

Other Identifiers

IM.AS1.46

Identifier Type: -

Identifier Source: org_study_id