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

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What is this study about?

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.

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

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

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

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 Study?

  • 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)

    Note: Hemoglobin is a protein in red blood cells that carries oxygen throughout the body

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Quironsalud Malaga Malaga Spain
Hospital Quironsalud Barcelona Barcelona Spain
Hospital Quironsalud Zaragoza Zaragoza Spain
Uavuxpfcwc Hjbcoydj Sxawpc Czo Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
15.10.2025

Trial locations

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.

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.

Trial ID:
2025-522004-24-00
Protocol code:
SID-WOMEN
Trial Phase:
Human Pharmacology (Phase I) – Other

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