Sucrosomial Iron and Iron Sulphate to Blood Donors

N/AActive Not RecruitingNCT05678647

Uppsala University Hospital120 enrolled

Overview

2 different oral iron supplementations after blood donation are compared.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Blood Donation

Interventions

Sucrosomial IronDRUG

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

Iron SulfateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Immunology and Transfusion Medicine, Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Side effects

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.

Time frame: One year

Secondary Outcomes

Symptoms

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.

Time frame: One year

Iron balance

Laboratory analyzes

Time frame: One Year

Data from ClinicalTrials.gov

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