Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic … (NCT05702970) | Clinical Trial Compass
UnknownPhase 4
Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency
258 participantsStarted 2024-01-15
Plain-language summary
The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF.
The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters.
Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures.
The study will involve randomization into 3 groups with a 1:1:1 ratio:
1. Control group \[standard of care\]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID.
2. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks.
3. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks
Who can participate
Age range
18 Years – 100 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:
NYHA functional class II-III due to symptomatic chronic HF and all the following:
* At least 3 weeks since the last hospitalization or emergency department access for acute HF decompensation.
* Optimal drug treatment for HF according to the European Society of Cardiology guidelines determined by the investigator (unless contraindications or treatment not tolerated).
* No changes in HF therapy dosage in the previous 2 weeks (except diuretics).
* No new HF therapy in the 3 weeks prior to recruitment.
* LVEF ≤45%.
* Brain Natriuretic Peptide (BNP) \>100 pg/mL and/or NT-proBNP \>400 pg/mL at pre-recruitment evaluation.
* Evidence of ID defined as ferritin \<100 ng/ml or TSAT \<20% in case of ferritin levels between 100 and 300 ng/ml.
* 25-OH-Vitamin D levels \<50 nmol/L.
* The subject must be able to complete the 6MWT.
* At least 18 years of age.
Exclusion Criteria:
* Myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke, coronary artery bypass, percutaneous intervention, or major thoracic or cardiac surgery within the previous 2 months.
* Clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy.
* Chronic anemia due to non-correctable causes other than ID and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia).
* Anemia due to Vitamin B12 or acid folic deficiency. Recruitment may be re-evaluated at least 6 weeks after the end of vitamin B12 an…
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.