Sucrosomial Iron and Iron Sulphate to Blood Donors

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05678647

Enrollment

120

Registered

2023-01-10

Start date

2023-01-31

Completion date

2026-01-01

Last updated

2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Donation

Brief summary

2 different oral iron supplementations after blood donation are compared.

Detailed description

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).

Interventions

DRUGSucrosomial Iron

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

DRUGIron Sulfate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Drugs: Oral sucrosomial Iron (SiderAl Forte®) and oral iron sulphate (Duroferon®) to blood donors

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Side effects	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

Measure	Time frame	Description
Symptoms	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.
Iron balance	One Year	Laboratory analyzes

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026