- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774057
Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients With IBD
Randomized Cross-Over Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients With Inflammatory Bowel Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ala I Sharara, MD
- Phone Number: 4765 01350000
- Email: as08@aub.edu.lb
Study Locations
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Beirut, Lebanon
- Recruiting
- American University of Beirut - Medical Center
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Contact:
- Ala' I. Sharara, MD
- Phone Number: 5345 009611350000
- Email: as08@aub.edu.lb
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Principal Investigator:
- Ala' I Sharara, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
2 pills daily. Contains
195 mg Iron supplement
Other Names:
|
Experimental: 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.
|
2 pills daily. Contains
195 mg Iron supplement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: The change of treatment related side effect frequency between baseline (pre-treatment) and end of treatment periods.
|
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.
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The change of treatment related side effect frequency between baseline (pre-treatment) and end of treatment periods.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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
|
Efficacy will be assessed for Captafer® and iron sulfate treatment at the end of the first 6 weeks before crossing over, and at the end of the next 6 weeks after crossing over.
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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
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Number of patients compliant and adherent to treatment intake assessed by paper logged pill counts conducted at 4 different time points.
Time Frame: End of 6 weeks before 2 weeks washout, and end of 6 weeks after 2 weeks of washout
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Number of patients compliant and adherent to treatment intake assessed by paper logged pill counts conducted at baseline prior to treatment initiation, after 6 weeks of first arm of treatment completion, at baseline following a 2 week washout period, and at the end of the 6 weeks of therapy following crossing over.
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End of 6 weeks before 2 weeks washout, and end of 6 weeks after 2 weeks of washout
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM.AS1.46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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