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Study comparing Sucrosomial Iron and Ferric Maltol treatment for women with iron deficiency

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on women with iron deficiency, a condition where the body lacks sufficient iron to produce adequate amounts of hemoglobin, a protein in red blood cells that carries oxygen throughout the body. The study compares two different iron supplements: Sucrosomial Iron and Ferric Maltol (Feraccru), which are both medications designed to treat iron deficiency.

The main purpose of this research is to determine how effective these two iron supplements are at helping patients achieve normal blood hemoglobin levels. The study will evaluate which medication works better at improving iron levels in women who have mild to moderate anemia, a condition where there aren't enough healthy red blood cells to carry adequate oxygen to the body's tissues.

During this 12-week study, participants will receive either Sucrosomial Iron or Ferric Maltol as oral capsules. The study will track how well each medication helps restore normal iron levels and improve symptoms related to iron deficiency, such as fatigue. The medications will also be compared for how well patients tolerate them and whether they experience any side effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your hemoglobin levels will be measured to confirm iron deficiency anemia
Additional laboratory tests will check your iron levels, including sideremia, ferritin, and TSAT
You will complete the FACIT Fatigue Scale questionnaire to assess your fatigue symptoms
Step 2
Treatment assignment
You will be randomly assigned to receive either Ferric Maltol or Sucrosomial Iron
If assigned to Ferric Maltol, you will take 30 mg hard capsules orally
Step 3
12-week treatment period
You will take the assigned medication for 12 weeks
Regular blood tests will monitor your hemoglobin levels
Your iron levels will be checked periodically
You will complete fatigue assessment questionnaires during the treatment
Any side effects or difficulties taking the medication should be reported
Step 4
Final assessment
Final blood tests will measure your hemoglobin and iron levels
You will complete a final fatigue assessment
The effectiveness of the treatment will be evaluated based on whether your hemoglobin reaches normal levels (12 g/dl or higher)
Any side effects experienced during the study will be documented

Who can join the trial?

5 criteria

Must be a female aged 18 or older
Must have either:
- Mild anemia (hemoglobin level between 11.0 and 12.0 grams per deciliter) or
- Moderate anemia (hemoglobin level between 8.0 and 11.0 grams per deciliter)
- Must be diagnosed with iron deficiency (a condition where the body doesn't have enough iron to produce adequate hemoglobin)
- Must be willing and able to read, understand, and sign the informed consent form before participating in the study

Who cannot join the trial?

14 criteria

Female patients who are pregnant or breastfeeding
Current participation in other clinical trials
Known allergic reactions to iron supplements
Presence of any serious medical conditions that could interfere with iron absorption
Recent blood transfusion (within the last 3 months)
Current use of other iron supplements
History of inflammatory bowel disease (conditions affecting digestive system like Crohn's disease or ulcerative colitis)
Active gastrointestinal bleeding (bleeding in stomach or intestines)
Severe liver or kidney problems
Males (as this study is designed for female participants only)
Age outside the adult range (18-65 years)
Hemochromatosis (a condition where body stores too much iron)
Recent major surgery (within the last 3 months)
Inability to follow study procedures or attend follow-up visits

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Verified sites

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

Hospital Quironsalud Zaragoza
Verified
Zaragoza, Spain
Hospital Universitari General De Catalunya
Verified
Sant Cugat Del Valles, Spain

Trial locations

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Investigated drugs

Sucrosomial Iron is a type of oral iron supplement designed to treat iron deficiency. It uses a unique technology that protects iron molecules with a phospholipid membrane, making it easier for the body to absorb the iron while reducing common side effects like stomach upset. This form of iron is specifically developed to be gentler on the digestive system. Ferric Maltol is an oral iron replacement medication used to treat iron deficiency. It combines iron with maltol, which helps the body absorb the iron more effectively. This medication is designed to be well-tolerated and can help increase iron levels in patients who have difficulty tolerating other iron supplements. Both medications are used to treat iron deficiency and aim to improve hemoglobin levels in women who have low iron levels. They represent different approaches to making iron supplementation more effective and better tolerated by patients.

What is already known about the treatment

Sucrosomial Iron
An innovative oral iron supplement that uses a unique phospholipid membrane technology to protect iron from stomach acid and enhance absorption in the intestines. This formulation helps reduce common gastrointestinal side effects associated with traditional iron supplements while effectively treating iron deficiency anemia. The medication works by delivering iron directly to the bloodstream through a protective sucrosome coating, which allows for better bioavailability and tolerance.
Ferric Maltol
An oral iron replacement therapy that combines ferric iron with maltol, forming a stable complex that enables better iron absorption in the digestive system. This medication is specifically designed for treating iron deficiency in adults, particularly those who have had an inadequate response to traditional oral iron supplements. The unique chemical structure helps minimize gastrointestinal irritation while providing effective iron supplementation to restore normal hemoglobin levels.

Investigated diseases

Iron Deficiency Anemia - A condition where the body doesn't have enough iron to produce adequate amounts of hemoglobin, a protein in red blood cells that carries oxygen throughout the body. It develops gradually as the body's iron stores become depleted. Common symptoms include fatigue, weakness, pale skin, shortness of breath, and decreased physical performance. The condition can affect people of all ages, but it's particularly common in women of childbearing age. Iron deficiency anemia typically develops slowly over time as iron levels in the blood and stored iron gradually decrease.