Sucrosomial Iron and Iron Sulphate to Blood Donors

Not Applicable

Active, not recruiting

• Conditions: Blood Donation
• Interventions: Drug: Sucrosomial Iron; Drug: Iron Sulfate

• Registration Number: NCT05678647
• Lead Sponsor: Uppsala University Hospital

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).

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-10
• Study Start: 2023-01-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral sucrosomial Iron (SiderAl Forte®)	Sucrosomial Iron	Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation
Oral iron sulphate (Duroferon®)	Iron Sulfate	Oral iron sulphate (Duroferon®) is given to blood donors after blood donation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Iron balance	One Year	Laboratory analyzes
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.

Trial Locations

Locations (1)

Clinical Immunology and Transfusion Medicine, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden