Anemia, Iron DeficiencyPhase 3NCT05225545
Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
A Phase 3 study testing Sucrosomial Iron and Oral Iron in people with Anemia, Iron Deficiency and Ulcerative Colitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency, Ulcerative Colitis
- What is being tested?
- Sucrosomial Iron and Oral Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 4 Nov 2019to 4 May 2024
- Phase
- Phase 3
- 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
- Proven Iron Deficiency Anemia (Hb < 12 for females and Hb < 13 for males AND iron saturation <20%)
- Hemoglobin level > 8g/dl
Who cannot join
- Age below 18
- Hemoglobin level < 8g/dl
- Recently hospitalized for disease flare (within 3 months)
- Hemoglobinopathies (including thalassemia)
- Isolated proctitis
- Indeterminate colitis
Show all 18Show fewer
- Known liver or kidney disease
- Known Celiac Disease
- Extensive 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 in the past 4 weeks
- Erythropoetin within the last 8 weeks
- Rheumatoid Arthritis
- History of menometrorrhagia or frequent epistaxis
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 Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.
Read the detailed description
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, and is encountered in one third of patients [1] and Anemia in Ulcerative Colitis is most commonly the result of iron-deficiency due to chronic blood loss through ulcerations in the colon.
Oral Iron supplementation has been used for the treatment of Iron Deficiency anemia but may cause disease exacerbation in patients with UC [2]. Iron also can increase cancer risk [3], and is associated with many side effects such as constipation, diarrhea, nausea, vomiting, abdominal pain and hyperchromia of feces. Furthermore, studies have shown that oral iron supplementation fails to resolve anemia in 2 of 3 IBD patients. [4]
Sucrosomial iron is a new preparation of iron pyrophosphate delivered within a phospholipid membrane and coated with sucrester (sucrose esters of fatty acids). it has been shown to have better absorption and higher bioavailability while minimizing side effects in multiple patient populations.
- Conditions
- Anemia, Iron Deficiency, Ulcerative Colitis
- Being tested
- Sucrosomial Iron, Oral Iron
- Keywords
- Sucrosomial Iron, Sideral Forte, Iron Supplementation, Iron Deficiency, Anemia, Ulcerative Colitis, Inflammatory Bowel Disease
- Medical subject headings
- Anemia, Iron-Deficiency, Colitis, Ulcerative, Iron Deficiencies, Anemia, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial IronDrug
Also called Sideral Forte
Experimental Arm
Oral IronDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Sucrosomial Iron | Experimental | These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily Receives: Drug: Sucrosomial Iron |
| Oral Iron Therapy | Active comparator | These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time Receives: Drug: Oral Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of experimental product
Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire
Measured: 12 weeks
Secondary outcomes (6)
Response to iron repletion
Hemoglobin
Measured: 12 weeks
Compliance and adherence
Regular Pill Counts
Measured: 12 weeks
Response to iron repletion
Hematocrit
Measured: 12 weeks
Response to iron repletion
Iron storage
Measured: 12 weeks
Response to iron repletion
Iron saturation
Measured: 12 weeks
Response to iron repletion
Ferritin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start4 Nov 2019
- Primary completion4 May 2024 (estimated)
- Study completion4 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharma M SAL, Lebanon
- Responsible party
- Sponsor
- Investigators
- Ala Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225545
- Sponsor's protocol ID
- BIO-2019-0046:
- Status last verified
- Dec 2023
- First submitted
- 9 Oct 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gasche C, Lomer MC, Cavill I, Weiss G. Iron, anaemia, and inflammatory bowel diseases. Gut. 2004 Aug;53(8):1190-7. doi: 10.1136/gut.2003.035758.
PubMed 15247190Carrier J, Aghdassi E, Cullen J, Allard JP. Iron supplementation increases disease activity and vitamin E ameliorates the effect in rats with dextran sulfate sodium-induced colitis. J Nutr. 2002 Oct;132(10):3146-50. doi: 10.1093/jn/131.10.3146.
PubMed 12368409Seril DN, Liao J, Yang GY, Yang CS. Oxidative stress and ulcerative colitis-associated carcinogenesis: studies in humans and animal models. Carcinogenesis. 2003 Mar;24(3):353-62. doi: 10.1093/carcin/24.3.353.
PubMed 12663492Lugg S, Beal F, Nightingale P, Bhala N, Iqbal T. Iron treatment and inflammatory bowel disease: what happens in real practice? J Crohns Colitis. 2014 Aug;8(8):876-80. doi: 10.1016/j.crohns.2014.01.011. Epub 2014 Jan 31.
PubMed 24486177
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05225545
- Acronym / sponsor ID
- BIO-2019-0046:
- Conditions
- Anemia, Iron Deficiency, Ulcerative Colitis
- Keywords
- Sucrosomial Iron, Sideral Forte, Iron Supplementation, Iron Deficiency, Anemia, Ulcerative Colitis, Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Pharma M SAL, Lebanon
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 4 May 2024 (estimated)
- Study completion
- 4 May 2024 (estimated)
- First posted
- 4 Feb 2022 (actual)
- 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.
The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.
Detailed description
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, and is encountered in one third of patients [1] and Anemia in Ulcerative Colitis is most commonly the result of iron-deficiency due to chronic blood loss through ulcerations in the colon.
Oral Iron supplementation has been used for the treatment of Iron Deficiency anemia but may cause disease exacerbation in patients with UC [2]. Iron also can increase cancer risk [3], and is associated with many side effects such as constipation, diarrhea, nausea, vomiting, abdominal pain and hyperchromia of feces. Furthermore, studies have shown that oral iron supplementation fails to resolve anemia in 2 of 3 IBD patients. [4]
Sucrosomial iron is a new preparation of iron pyrophosphate delivered within a phospholipid membrane and coated with sucrester (sucrose esters of fatty acids). it has been shown to have better absorption and higher bioavailability while minimizing side effects in multiple patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrosomial Iron | Experimental | Drug: Sucrosomial IronThese patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily |
| Oral Iron Therapy | Active comparator | Drug: Oral IronThese patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18
- Confirmed diagnosis of Ulcerative Colitis
- Proven Iron Deficiency Anemia (Hb < 12 for females and Hb < 13 for males AND iron saturation <20%)
- Hemoglobin level > 8g/dl
Key exclusion criteria (18 listed)
- Age below 18
- Hemoglobin level < 8g/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 |
|---|---|---|
| Sucrosomial IronAlso: Sideral ForteExperimental Arm | Drug | Sucrosomial Iron |
| Oral IronActive Comparator | Drug | Oral Iron Therapy |
Primary outcome
Tolerability of experimental product
Time frame: 12 weeks
Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire
6 secondary outcomes
Response to iron repletion
Time frame: 12 weeks
Compliance and adherence
Time frame: 12 weeks
Response to iron repletion
Time frame: 12 weeks
Response to iron repletion
Time frame: 12 weeks
Response to iron repletion
Time frame: 12 weeks
Response to iron repletion
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 15247190Gasche C, Lomer MC, Cavill I, Weiss G. Iron, anaemia, and inflammatory bowel diseases. Gut. 2004 Aug;53(8):1190-7. doi: 10.1136/gut.2003.035758.
- Background: PubMed 12368409Carrier J, Aghdassi E, Cullen J, Allard JP. Iron supplementation increases disease activity and vitamin E ameliorates the effect in rats with dextran sulfate sodium-induced colitis. J Nutr. 2002 Oct;132(10):3146-50. doi: 10.1093/jn/131.10.3146.
- Background: PubMed 12663492Seril DN, Liao J, Yang GY, Yang CS. Oxidative stress and ulcerative colitis-associated carcinogenesis: studies in humans and animal models. Carcinogenesis. 2003 Mar;24(3):353-62. doi: 10.1093/carcin/24.3.353.
- Background: PubMed 24486177Lugg S, Beal F, Nightingale P, Bhala N, Iqbal T. Iron treatment and inflammatory bowel disease: what happens in real practice? J Crohns Colitis. 2014 Aug;8(8):876-80. doi: 10.1016/j.crohns.2014.01.011. Epub 2014 Jan 31.
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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.
Ala Sharara, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sucrosomial Iron and Oral Iron in people with Anemia, Iron Deficiency and Ulcerative Colitis, 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 4 inclusion and 18 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 31 Jan 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ali El Mokahal, MD (+961350000 ext. 5909, ae136@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of experimental product (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225545, which also lists 4 linked publications.
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 31 Jan 2024.