Sucrosomial Iron and Iron Sulphate to Blood Donors

Blood Donation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05678647
• Other study ID #: FOU2022-00167 980506
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

2 different oral iron supplementations after blood donation are compared.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Donation

Intervention

Drug:
• Sucrosomial Iron
20 capsules of Sucrosomial Iron 30 mg is given after blood donation
• Iron Sulfate
20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation

Locations

Country	Name	City	State
Sweden	Clinical Immunology and Transfusion Medicine, Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Birgegard G, Schneider K, Ulfberg J. High incidence of iron depletion and restless leg syndrome (RLS) in regular blood donors: intravenous iron sucrose substitution more effective than oral iron. Vox Sang. 2010 Nov;99(4):354-61. doi: 10.1111/j.1423-0410.2010.01368.x. — View Citation

Fabiano A, Brilli E, Mattii L, Testai L, Moscato S, Citi V, Tarantino G, Zambito Y. Ex Vivo and in Vivo Study of Sucrosomial(R) Iron Intestinal Absorption and Bioavailability. Int J Mol Sci. 2018 Sep 12;19(9):2722. doi: 10.3390/ijms19092722. — View Citation

Gomez-Ramirez S, Brilli E, Tarantino G, Munoz M. Sucrosomial(R) Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097. — View Citation

Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13. — View Citation

Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Iron balance	Laboratory analyzes	One Year