A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resista… (NCT04778072) | Clinical Trial Compass
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A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
Ireland60 participantsStarted 2018-10-08
Plain-language summary
A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron. Subjects with intolerance and treatment failure due to oral iron (male and female subjects, aged 18 to 55 years, with mild to moderate iron deficiency, with or without anaemia) are eligible. Sixty subjects are randomised into three groups (14 mg elemental iron, 25mg elemental iron and 50mg elemental iron daily). The primary objective is to assess adherence/persistence (including using pill counts). Secondary objectives are to assess gastrointestinal tolerability, haematological efficacy and health related quality of life.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be able to give written informed consent
. Be between 18 and 55 years of age
. Have ferritin levels \<30 µg/L
. Have a history of intolerance to oral iron
. Have mild to moderate anaemia (haemoglobin ≥9.5 g/dL and \<12.0 g/dL for females and ≥10.0 g/dL and \<13.0 g/dL for males, up to 30 patients) or no anaemia (up to 30 patients)
. Be in generally good health as determined by the investigator
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects adherent/persistent (6 weeks)
Timeframe: 6 weeks
2
Proportion of subjects adherent/persistant (12 weeks)
. A history of dairy allergy or are hypersensitive to any of the components of the test product,
. Are currently taking any iron supplements, or have done so in the previous 2 weeks,
. Current inflammatory bowel disease (Crohn's disease or ulcerative colitis),
. Severe anemia (females with hemoglobin \<9.5 g/dL and males with hemoglobin \<10.0 g/dL)
. Females that have started menopause,
. Females using extended-cycle birth control pills
. Have a significant acute or chronic, unstable and untreated disease or any condition, which contraindicates, in the investigator's judgement, entry to the study,
. Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; for example, no concurrent medication which interferes with the absorption of iron (e.g. tetracyclines, calcium supplements),