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Active Not RecruitingNCT05678647

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
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Uppsala University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGSucrosomial Iron20 capsules of Sucrosomial Iron 30 mg is given after blood donation
DRUGIron Sulfate20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation

Timeline

Start date
2023-01-31
Primary completion
2025-10-01
Completion
2026-01-01
First posted
2023-01-10
Last updated
2025-04-23

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05678647. Inclusion in this directory is not an endorsement.

Sucrosomial Iron and Iron Sulphate to Blood Donors (NCT05678647) · Clinical Trials Directory