NCT05678647

Brief Summary

2 different oral iron supplementations after blood donation are compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

November 30, 2022

Last Update Submit

April 28, 2026

Conditions

Blood Donation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Symptoms

    One year

  • Iron balance

    One Year

Study Arms (2)

Oral sucrosomial Iron (SiderAl Forte®)

EXPERIMENTAL

Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation

Drug: Sucrosomial Iron

Oral iron sulphate (Duroferon®)

ACTIVE COMPARATOR

Oral iron sulphate (Duroferon®) is given to blood donors after blood donation

Drug: Iron Sulfate

Interventions

Sucrosomial IronDRUG

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

Also known as: SiderAl Forte®
Oral sucrosomial Iron (SiderAl Forte®)
Iron SulfateDRUG

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

Also known as: Duroferon®
Oral iron sulphate (Duroferon®)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Immunology and Transfusion Medicine, Uppsala University Hospital

Uppsala, 75237, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 30287781BACKGROUND

  • 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.

    PMID: 30213039BACKGROUND

  • 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.

    PMID: 20598107BACKGROUND

  • 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.

    PMID: 25395392BACKGROUND

  • 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.

    PMID: 25700159BACKGROUND

MeSH Terms

Interventions

sucrosomial ironIron-Dextran Complex

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Norbert Lubenow, PhD

    Clinical Immunology and Transfusion Medicine Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Drugs: Oral sucrosomial Iron (SiderAl Forte®) and oral iron sulphate (Duroferon®) to blood donors
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 30, 2022

First Posted

January 10, 2023

Study Start

January 31, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Only aggregated data will be shared.

Locations

SE(1)