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Effect of Ferric Carboxymaltose, Ferrous Sulfate, and Sodium Chloride vs Placebo on Physical Performance in Frail Elderly with Iron Deficiency and Cardiovascular Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on older adults who are both frail and have low iron levels together with cardiovascular disease. Frailty means reduced strength and stamina, while iron deficiency can cause tiredness and weakness. The trial compares three options: an infusion of the iron drug ferric carboxymaltose given through a vein, a daily oral tablet of ferrous sulphate, and a matching placebo. The main goal is to see whether adding iron improves physical ability, overall well‑being, and thinking skills over a year.

Participants are randomly assigned to one of the three groups and receive their assigned treatment for 12 months. At the start and at the end of the study, simple tests measure how well they can walk, stand, and balance, and questionnaires ask about daily life and health. Throughout the year, any falls or hospital stays are recorded, and regular check‑ins ensure safety and collect the needed information.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After you agree to take part, you sign a consent form.
Your identity is recorded and you receive a participant number.
Step 2
Baseline assessment
Research staff measure your physical performance using the short physical performance battery.
They also ask you about quality of life and test your memory and thinking.
Blood tests confirm iron deficiency and other health status.
Step 3
Randomisation
You are assigned by a computer to one of three groups: intravenous iron, oral iron, or placebo.
The assignment is unknown to you and to the staff who evaluate the outcomes.
Step 4
Intravenous iron infusion (ferinject)
You receive an infusion of ferinject, which contains ferric carboxymaltose, 20 ml (50 mg iron per ml) given through a vein.
The infusion is administered once at the start of the 12‑month treatment period.
You are observed for a short time after the infusion for any reaction.
Step 5
Oral iron tablets (tardyferon)
You take one tardyferon tablet each day.
Each tablet provides 80 mg of iron as dried ferrous sulfate, equivalent to 247.25 mg of the active substance.
The tablet is swallowed with water, preferably with food, for the entire 12‑month period.
Step 6
Placebo infusion (saline)
You receive an infusion of 0.9% sodium chloride solution (saline), 20 ml, administered through a vein once at the start, matching the iron infusion schedule.
Step 7
Placebo oral tablets
You take placebo tablets that look like the iron tablets, one tablet each day for 12 months.
Step 8
Ongoing monitoring
Throughout the 12 months you attend scheduled visits where blood tests and safety checks are performed.
You are asked to report any falls, hospital stays, or side effects.
Step 9
Final assessment at month 12
At the end of the 12‑month period you repeat the same physical performance test, quality of life questionnaire, and cognitive test as at baseline.
The results are compared with the baseline measurements.

Who can join the trial?

7 criteria

Age 65 years or older
Diagnosed cardiovascular disease (heart or blood‑vessel problems) such as high blood pressure treated with medication, irregular heartbeat (atrial fibrillation), heart failure, blocked heart arteries confirmed by a procedure or a past heart attack, stroke or related brain vessel disease confirmed by a procedure or a past stroke, or leg artery disease confirmed by a procedure or a past serious leg blood‑flow problem.
Frailty status confirmed by a score of 5 or more out of 15 on the Tilburg Frailty Indicator (TFI), a questionnaire that measures weakness, health problems, and loss of independence.
Poor or moderate physical performance confirmed by a score of 9 or less out of 12 on the Short Physical Performance Battery (SPPB), a simple set of tests that check balance, walking speed, and ability to stand up from a chair.
Iron deficiency defined as a transferrin saturation (TSAT) lower than 20%, meaning the blood’s iron‑carrying protein is not carrying enough iron.
Provided written informed consent, meaning you have read and agreed in writing to take part in the study.
Ability to follow the study treatment schedule and complete all study questionnaires and assessments on your own.

Who cannot join the trial?

17 criteria

Bed‑bound status: unable to get out of bed.
Vitamin D3 deficiency without taking enough supplements.
Liver disease or liver enzyme tests (AST or ALT) more than three times the normal limit, or active hepatitis B or hepatitis C infection, including if you are on antiviral medicines.
Allergy (hypersensitivity) to any of the study medicines or their inactive ingredients.
Having received erythropoiesis‑stimulating drugs, intravenous iron, or a blood transfusion within the past 6 months.
Having a medical reason that now requires those same treatments (for example, severe anemia or kidney disease needing dialysis).
Active cancer or cancer that has not been in stable remission for at least 3 years, except for certain non‑invasive skin cancers.
Participating in another drug or device study within the last 3 months (or within five drug half‑lives, whichever is longer).
Any condition that would make it impossible to follow the study procedures.
Body weight below 35 kg (about 77 lb).
Diagnosis of dementia that requires medication for memory problems.
Diagnosis of depression that requires antidepressant medication.
Being in the hospital (urgent or planned), including for surgery, within the past 4 weeks.
Having a temperature higher than 38 °C (100.4 °F) or an infection that needs antibiotics within the past week.
Hemoglobin level (a measure of red blood cells) lower than 10 g/dL or higher than 15 g/dL.
Serum ferritin level (a measure of iron stores) higher than 400 ng/mL.
Vitamin B12 and/or folic acid deficiency that is not being treated effectively.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gornoslaskie Centrum Mwdyczne
Verified
Katowice, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Responsive
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

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Investigated drugs

Tardyferon
is an oral iron tablet that contains ferrous sulfate. In the trial it is used as the standard oral iron treatment to compare how well it improves strength, daily activities, and thinking abilities in older people with low iron levels and heart disease.
Ferinject
is an intravenous (IV) iron preparation that contains ferric carboxymaltose. In the study it is given by infusion to see if delivering iron directly into the bloodstream works better than a pill for enhancing physical performance, quality of life, and cognitive function in the same group of frail elderly participants.

What is already known about the treatment

0,9% Sodium Chloride–Braun, 9 mg/ml, roztwór do infuzji
This product is given by intravenous infusion as a sterile saline solution that contains only sodium chloride. It is used in the trial as a placebo but in clinical practice it is a common fluid for restoring electrolytes and fluid balance. The solution works by supplying sodium and chloride ions to keep the body’s water balance normal. It is classified as an electrolyte solution (ATC B05BB01).
Tardyferon, 80 mg, tabletki powlekane o przedłużonym uwalnianiu
The tablets are taken orally and release iron slowly over time. They are an approved oral iron supplement used to treat iron‑deficiency anemia, especially in older adults. The ferrous sulfate provides iron that is absorbed in the gut and incorporated into hemoglobin to carry oxygen. It belongs to the class of iron preparations (ATC B03AA07).
Ferinject 50 mg żelaza/ml dyspersja do wstrzykiwań/infuzji
This medication is administered by intravenous infusion, delivering a concentrated iron complex directly into the bloodstream. It is an approved parenteral iron product for treating iron deficiency when oral iron is ineffective or not tolerated. Ferric carboxymaltose releases iron in a controlled way, allowing rapid replenishment of body iron stores and supporting hemoglobin production. It is classified as an intravenous iron preparation (ATC B03AC).

Investigated diseases

Iron deficiency anemia
A condition in which the body does not have enough iron to make normal amounts of hemoglobin, the protein in red blood cells that carries oxygen. It often begins with low iron stores and can progress to reduced red blood cell production, causing tiredness and weakness. In older adults, the shortage may develop slowly over months or years as diet, absorption, or blood loss affect iron levels. As the anemia worsens, the body may show pale skin, shortness of breath with activity, and a slower recovery from everyday tasks. The condition can become more noticeable when the demand for oxygen increases, such as during illness or physical exertion.
Physical frailty
A syndrome characterized by decreased strength, endurance, and overall physiological reserve, making everyday activities more difficult. It usually starts with subtle loss of muscle mass and slower walking speed, then advances to difficulty rising from a chair or climbing stairs. Over time, balance may worsen, and small stresses like a minor infection can lead to noticeable decline in function. The progression is often gradual, with increasing reliance on assistance for daily tasks. The condition reflects an overall decline in the body's ability to cope with stressors.
Cardiovascular disease
A group of disorders affecting the heart and blood vessels, including conditions such as coronary artery disease and heart failure. It typically begins with the buildup of fatty deposits in artery walls, which slowly narrows the vessels and reduces blood flow. As the narrowing continues, the heart may have to work harder, leading to changes in heart muscle function. Over time, this can cause symptoms like chest discomfort, reduced exercise capacity, and swelling in the legs. The disease often progresses quietly, becoming more apparent when the circulatory system is stressed.