Can a gentler iron pill break the anemia cycle in IBD?
NCT ID NCT07739368
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial tests whether ferric maltol, an oral iron supplement, can safely raise hemoglobin levels in adults with inflammatory bowel disease (IBD) who have iron deficiency anemia and have not responded to or cannot tolerate standard ferrous iron pills. Participants take either ferric maltol or a placebo twice daily for 12 weeks. The main goal is to see if hemoglobin improves more with ferric maltol than with placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ferric maltol capsules (an oral iron supplement)
- What this could lead to
- If effective, this could offer a well-tolerated oral option to treat iron deficiency anemia in people with inflammatory bowel disease who cannot use standard iron pills.
- What could go wrong
- The trial is relatively small and early-stage, so results may not hold in larger groups. Ferric maltol can still cause gastrointestinal side effects, and its benefit over placebo is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
122 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Mar 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years at the time of signing the informed consent form, male or female; * UC or CD, with a Simple Clinical Colitis Activity Index (SCCAI) score \< 5 or a Crohn's Disease Activity Index (CDAI) score \< 220 at the screening visit; * Anaemia, with Hb levels tested at the screening visit as follows: Hb ≥ 85 g/L and \< 110 g/L for females, Hb ≥ 85 g/L and \< 120 g/L for males; * SIron deficiency, defined as ferritin \< 30 µg/L at the screening visit, or ferritin \< 100 µg/L and transferrin sa Exclusion Criteria: * Anaemia due to any cause other than iron deficiency, including but not limited to: untreated or untreatable severe malabsorption syndrome; * Subjects who have received the following treatments within 12 weeks prior to randomization 1. Blood transfusion 2. Erythropoietin 3. Prolyl hydroxylase inhibitors * Subjects who have received the following treatments within 4 weeks prior to screening 1. Oral/intramuscular/intravenous iron preparations (including sustained-release iron preparations) 2. Immunosuppressants known to induce anaemia, including but not limited to methotrexate, cyclosporine A, or tacrolimus 3. Traditional Chinese medicine prescriptions, herbs, or proprietary Chinese medicines with blood-tonifying effects (with anaemia as an indication in the package insert) * Vitamin B12 or folic acid measured at the screening visit was below the lower limit of normal; * Subjects with known hypersensitivity or allergy to ferric maltol or any component of the investigational medicinal product; * Subjects with known contraindications to iron preparation therapy, such as hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead poisoning-induced anaemia; * Subjects with creatinine \> 1.5 times the upper limit of normal measured at the screening visit; * Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal measured at the screening visit; * Subjects with severe cardiovascular, hepatic, renal, hematological, gastrointestinal, immune, endocrine, metabolic, or central nervous system diseases, which in the investigator's opinion might adversely affect the subject's safety and/or the efficacy of the investigational drug; * Subjects with a history of malignancy within the past 5 years, except for excised basal cell carcinoma in situ; * Subjects with significant neurological or psychiatric disorders leading to disorientation, memory impairment, or inability to report accurately, which might interfere with treatment compliance, study conduct, or interpretation of results (e.g., Alzheimer's disease, depression, anxiety, schizophrenia or other psychiatric disorders, alcohol or drug abuse); * Subjects who have participated in another interventional clinical study within 4 weeks prior to randomization or would participate during this study; * Subjects who are inmates of psychiatric hospitals or prisons; * Female subjects who are pregnant or breastfeeding; * Other situations deemed by the investigator as unsuitable for the patient to participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jiangsu Aosaikang Pharm
Nanjing, China
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