Iron Deficiency AnemiaPhase 4NCT02774057
Trial of Captafer® vs. Oral Iron Sulfate in the Treatment of Iron Deficiency Anemia in Patients With IBD
A Phase 4 study testing Captafer® and Iron Sulfate in people with Iron Deficiency Anemia and Inflammatory Bowel Disease, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, Inflammatory Bowel Disease
- What is being tested?
- Captafer® and Iron Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLebanon
- Study dates
- Mar 2016to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age below 18
- Hemoglobin level < 8 g/dL
- Recently hospitalized for disease flare (within 3 months)
- Hemoglobinopathies (including thalassemia)
- Isolated proctitis
- indeterminate colitis
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut - Medical Center
Beirut
Ala' I. Sharara, MD, 009611350000 ext. 5345, as08@aub.edu.lb
Ala' I Sharara, MD
About this study
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
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.
Read the 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
- Being tested
- Captafer®, Iron Sulfate
- Keywords
- Captafer®, Iron Sulfate, Iron deficiency anemia, inflammatory bowel disease
- Medical subject headings
- Anemia, Iron-Deficiency, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Iron SulfateDrug
Also called Ironorm
195 mg Iron supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Captafer®; Drug: Iron Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: End of 6 weeks before 2 weeks washout, and end of 6 weeks after 2 weeks of washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala'a Sharara, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774057
- Sponsor's protocol ID
- IM.AS1.46
- Status last verified
- Jan 2017
- First submitted
- 6 Apr 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02774057
- Acronym / sponsor ID
- IM.AS1.46
- Conditions
- Iron Deficiency Anemia, Inflammatory Bowel Disease
- Keywords
- Captafer®, Iron Sulfate, Iron deficiency anemia, inflammatory bowel disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial therapy with Captafer® | Experimental | Drug: Captafer®, Drug: Iron SulfateThis 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. |
| Initial therapy with Iron Sulfate | Experimental | Drug: Captafer®, Drug: Iron SulfateThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- Age below 18
- Hemoglobin level < 8 g/dL
- Recently hospitalized for disease flare (within 3 months)
- Hemoglobinopathies (including thalassemia)
- Isolated proctitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Initial therapy with Captafer®, Initial therapy with Iron Sulfate |
| Iron SulfateAlso: Ironorm195 mg Iron supplement | Drug | Initial therapy with Captafer®, Initial therapy with Iron Sulfate |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Captafer® and Iron Sulfate in people with Iron Deficiency Anemia and Inflammatory Bowel Disease, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ala I Sharara, MD (01350000 ext. 4765, as08@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.