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Can a gentler iron pill break the anemia cycle in IBD?

NCT ID NCT07739368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Sep 2021

Finished

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

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

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

  • Jiangsu Aosaikang Pharm

    Nanjing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.