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

NCT02774057 | Unknown Phase 4 DMC

• 1 other identifier: IM.AS1.46
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; Inflammatory Bowel Disease

Keywords

Captafer®; Iron Sulfate; Iron deficiency anemia; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Tolerability to Iron sulfate and Captafer® assessed by the number of patients suffering from treatment related side effects using a Treatment Tolerability Assessment Questionnaire 4 point numerical scale (0,1,2,3).

  A 4 point (0,1,2,3) numerical scale will be used to assess the presence and frequency of drug related side effects experienced throughout the study, with scoring done at 4 instances: at baseline prior to initiating the first arm of therapy, at the end of the 6 week treatment period, at baseline after the completion of a 2 week washout period and prior to crossing over, and at the end of the cross over 6 week treatment period. Scores are as follows: 0 = Never, 1 = 2 to 3 times per month, 2 = 2 to 3 times per week, and 3 = daily.

  The change of treatment related side effect frequency between baseline (pre-treatment) and end of treatment periods.

Secondary Outcomes (2)

• Number of patients responding to therapy by measuring the change in the following laboratory measures Hemoglobin, Hematocrit, Iron, Total Iron Binding Capacity, Ferritin, Transferrin Saturation and c-reactive protein.

  The change in hemoglobin, hematocrit, iron, TIBC, ferritin, transferrin saturation and c-reactive protein between baseline (pretreatment), following 6 weeks of first arm of therapy, at baseline post 2 week washout period, and 6 weeks post crossover

• Number of patients compliant and adherent to treatment intake assessed by paper logged pill counts conducted at 4 different time points.

  End of 6 weeks before 2 weeks washout, and end of 6 weeks after 2 weeks of washout

Study Arms (2)

Initial therapy with Captafer®

EXPERIMENTAL

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.

Drug: Captafer®; Drug: Iron Sulfate

Initial therapy with Iron Sulfate

EXPERIMENTAL

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.

Drug: Captafer®; Drug: Iron Sulfate

Interventions

Captafer® 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

Initial therapy with Captafer®; Initial therapy with Iron Sulfate

Iron Sulfate DRUG

195 mg Iron supplement

Also known as: Ironorm

Initial therapy with Captafer®; Initial therapy with Iron Sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Inflammatory Bowel Diseases

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Ala I Sharara, MD

CONTACT

01350000; as08@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Gastroenterology Department

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: May 17, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)