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New iron supplement may be kinder to Kids' stomachs

NCT ID NCT05126901

Disease control Sponsor: Shield Therapeutics Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new iron supplement called ferric maltol (given as an oral suspension) against the standard ferrous sulfate liquid in children aged 2 to 17 with iron-deficiency anaemia, and also tested ferric maltol alone in infants aged 1 month to 2 years. The goal was to see if ferric maltol is safer and causes fewer stomach problems over 12 weeks. Researchers measured changes in haemoglobin and ferritin levels to check effectiveness.

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 (an iron supplement)
What this could lead to
If it works, this could offer a better-tolerated iron supplement for children with iron-deficiency anaemia, potentially reducing stomach side effects.
What could go wrong
This is a small, completed phase 3 trial with only 65 participants, so results may not apply to all children. The new drug may still cause side effects or not work better than the standard treatment.

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

65 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2024

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

1 month to 17 years

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: 1. Patient is willing and able to comply with the study requirements and to provide written informed consent. In the case of patients under the age of legal consent, the legal guardian(s) must provide informed consent and the patient should provide assent per local and national requirements. 2. Age ≥1 month and ≤17 years at the time of informed consent 3. Subjects must have iron deficiency anaemia defined by the following criteria, as measured by the central laboratory at the screening visit Haemoglobin thresholds define anaemia by age and gender: Children (1 m - \< 5 yrs) \<11.0 g/dl Children (5 yrs - \< 12 yrs) \<11.5 g/dl Children (12 yrs) \<12.0 g/dl Female child (≥13 yrs) \<12.0 g/dl Male child (≥13 yrs) \<13.0 g/dl and Ferritin thresholds define anaemia by: ferritin \<30 µg/L, or ferritin \<50 µg/L with transferrin saturation (TSAT) \<20%, 4. Female subjects of childbearing potential must agree to use a highly effective method of contraception (which includes complete abstinence) until study completion and for at least 4 weeks following their final study visit. Highly effective contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), a vasectomised partner and oral contraceptive medications. The need for contraception and compliance with contraception requirements will be assessed at every visit for adolescent patients, and urine pregnancy testing will be performed at each visit for female subjects of childbearing potential. Exclusion Criteria: 1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to, a. Untreated or untreatable severe malabsorption syndrome 2. Subjects who have received prior to Screening: 1. Within 28 days intramuscular or intravenous (IV) injection or administration of depot iron preparation. 2. Within 7 days single agent iron preparations and during the study. 3. Within 12 weeks of blood transfusion or is scheduled to have blood transfusion or donation during the study period 4. Within 28 days erythropoiesis stimulating agents and during the study period 5. Within 14 days COVID-19 vaccination 3. Subjects with vitamin B12 or folic acid deficiency as determined by the central laboratory screening results. Subjects may start vitamin B12 or folate replacement and rescreen after at least 2 weeks. 4. Has concomitant disease that would significantly compromise iron absorption or absorbed iron utilization such as swallowing disorders and/or extensive small bowel resection. 5. History of active peptic ulcer 6. Has chronic renal disease (eGFR \<60 mL/min/m2), as assessed at Screening based on serum creatinine. 7. Known hypersensitivity or allergy to either the active substance or excipients of ferric maltol or ferrous sulfate. 8. Has a known contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia. 9. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST)\>2.0 times upper normal limit as measured at the Screening visit. 10. Active acute inflammatory disease, including IBD flare or disease exacerbation, which in the opinion of the Investigator, is clinically significant. 11. Active chronic or acute infectious diseases requiring antibiotic treatment. 12. Pregnant or breast feeding. 13. Concomitant medical conditions with extensive active bleeding, other than menstrual cycles; subjects who suffer from menorrhagia may be included at the Investigator's discretion. 14. Scheduled or expected hospitalisation and/or surgery during the course of the study 15. Participation in any other interventional clinical study within 28 days prior to Screening. 16. Diagnosed to be COVID-19 positive by (SARS-CoV-2-RT-PCR positive) within 28 days prior to screening. 17. Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, respiratory or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or objectives of the study drug or severely limit the lifespan of the subject. 18. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment.

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Conditions

The condition(s) this trial relates to.

anemia iron deficiency anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia Iron-deficiency

Contacts and locations

Locations

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, United Kingdom

  • BRCR Global Puerto

    San Juan, 00907, Puerto Rico

  • BRCR Global Texas

    Edinburg, Texas, 78539, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Eminent Clinical Research and Associates

    North Lauderdale, Florida, 33068, United States

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Homestead Research Institute

    Homestead, Florida, 33030, United States

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Kissimmee Clinical Research Corp

    Kissimmee, Florida, 34743, United States

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Medical Research of Westcheste

    Miami, Florida, 33165, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405, United States

  • Newham University Hospital

    London, United Kingdom

  • Noah's Ark Children's Hospital for Wales

    Cardiff, CF14 4XW, United Kingdom

  • Nottingham University Hospitals

    Nottingham, NG7 2UH, United Kingdom

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033, United States

  • Royal Hospital for Sick Children - Edinburgh

    Edinburgh, EH16 4TJ, United Kingdom

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106, United States

  • The Center for Clinical Trials

    Saraland, Alabama, 36571, United States

  • Zion Research

    Katy, Texas, 77494, United States

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