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.

2 different oral iron supplementations after blood donation are compared.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Donation
• Intervention / Treatment: Drug: Sucrosomial Iron; Drug: Iron Sulfate

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75237
    • Clinical Immunology and Transfusion Medicine, Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Investigators: Principal Investigator: Norbert Lubenow, PhD, Clinical Immunology and Transfusion Medicine Uppsala University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: FOU2022-00167 980506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregated data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No