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

NCT02774057 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-25

No results posted yet for this study

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

Interventions

DRUG

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

DRUG

Iron Sulfate

195 mg Iron supplement

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • Lebanon

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02774057 on ClinicalTrials.gov