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OpenTrials
Completed

NCT Number: NCT05678647

Sucrosomial Iron and Iron Sulphate to Blood Donors

2 different oral iron supplementations after blood donation are compared.

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Key information

Conditions

Blood Donation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Immunology and Transfusion Medicine, Uppsala University Hospital

Uppsala, 75237, Sweden

About this study

Iron depletion is common in regular blood donors. During a blood donation the donor loses 200-250 mg iron. The routine at our donor sites is to give donors 20 tablets of iron sulphate (Duroferon®) 100 mg after blood donation.

In this study we will compare two different iron supplementations given after blood donation. 60 donors are given oral sucrosomial Iron (SiderAl Forte®) and 60 donors are given oral iron sulphate (Duroferon®) after 4 successive blood donation.

The primary purpose of this study is to compare the side effects of sucrosomial Iron and iron sulphate and to investigate if the iron balance can be maintained with sucrosomial iron.

After each blood donation the donors are asked to answer a questionary with questions about side effects and symptoms of Restless legs syndrome/Willis-Ekbom (symptoms associated with iron deficiency).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.

Exclusion criteria

Donors who cannot be accepted for blood donation anymore because they do not fulfill the Swedish criteria for blood donation.

Treatment and study plan

Sucrosomial Iron

Drug

20 capsules of Sucrosomial Iron 30 mg is given after blood donation

Other names: SiderAl Forte®

iron sulfate

Drug

20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation

Other names: Duroferon®

Primary outcomes

  1. Side effects

    Time frame: One year

    The side effects are compared. At every visit the donors are asked to answer a questionary with questions about side effects.

    The amount and severity of the side effects will be compared between the two groups with different iron supplementations.

Secondary outcomes

  1. Symptoms

    Time frame: One year

    Symptoms of Restless legs syndrome/Willis-Ekbom syndrom. At every visit the donors are asked to answer a questionary with questions about symptoms of restless legs.

    The amount and severity of the symptoms of the two groups with different iron supplementations will be compared.

  2. Iron balance

    Time frame: One Year

    Laboratory analyzes

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study title

Randomized Open Comparative Trial of Oral Sucrosomial Iron (SiderAl Forte®) and Oral Iron Sulphate (Duroferon®) to Blood Donors.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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