Sucrosomial Iron and Iron Sulphate to Blood Donors

Study Overview
=================
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).

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

Conditions
-----------------
Blood Donation

Intervention / Treatment
-----------------
* Drug: Sucrosomial Iron
* Drug: Iron Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Drugs: Oral sucrosomial Iron (SiderAl Forte®) and oral iron sulphate (Duroferon®) to blood donors
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral sucrosomial Iron (SiderAl Forte®)<br>Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation | Drug: Sucrosomial Iron<br>* 20 capsules of Sucrosomial Iron 30 mg is given after blood donation<br>* Other names: SiderAl Forte®;|
| Active Comparator: Oral iron sulphate (Duroferon®)<br>Oral iron sulphate (Duroferon®) is given to blood donors after blood donation | Drug: Iron Sulfate<br>* 20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation<br>* Other names: Duroferon®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 
| Iron balance | Laboratory analyzes | One Year |