Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 5:16 PM
Study NCT ID:
NCT02774057
Status:
UNKNOWN
Last Update Posted:
2017-01-25
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients With IBD
Sponsor:
American University of Beirut Medical Center
Organization:
Study Overview
Official Title:
Randomized Cross-Over Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients With Inflammatory Bowel Disease
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: