Sucrosomial Iron and Iron Sulphate to Blood Donors

Uppsala University Hospital

Status: Active, not recruiting

Conditions: Blood Donation

Treatments: Drug: Sucrosomial Iron; Drug: Iron Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05678647

FOU2022-00167 980506

Details and patient eligibility

About

2 different oral iron supplementations after blood donation are compared.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Oral sucrosomial Iron (SiderAl Forte®)

Experimental group

Description:

Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation

Treatment:

Drug: Sucrosomial Iron

Oral iron sulphate (Duroferon®)

Active Comparator group

Description:

Oral iron sulphate (Duroferon®) is given to blood donors after blood donation

Treatment:

Drug: Iron Sulfate