Blood DonationNCT05678647
Sucrosomial Iron and Iron Sulphate to Blood Donors
A study testing Sucrosomial Iron and Iron Sulfate in people with Blood Donation, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
2 different oral iron supplementations after blood donation are compared. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Donation
- What is being tested?
- Sucrosomial Iron and Iron Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.
Who cannot join
- Donors who cannot be accepted for blood donation anymore because they do not fulfill the Swedish criteria for blood donation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Immunology and Transfusion Medicine, Uppsala University Hospital
Uppsala, 75237
About this study
Official title: 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.
Read the 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).
- Conditions
- Blood Donation
- Being tested
- Sucrosomial Iron, Iron Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrosomial IronDrug
Also called SiderAl Forte®
20 capsules of Sucrosomial Iron 30 mg is given after blood donation
Iron SulfateDrug
Also called Duroferon®
20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation
| Study group | Role | What they receive |
|---|---|---|
| Oral sucrosomial Iron (SiderAl Forte®) | Experimental | Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation Receives: Drug: Sucrosomial Iron |
| Oral iron sulphate (Duroferon®) | Active comparator | Oral iron sulphate (Duroferon®) is given to blood donors after blood donation Receives: Drug: Iron Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (2)
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.
Measured: One year
Iron balance
Laboratory analyzes
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start31 Jan 2023
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drugs: Oral sucrosomial Iron (SiderAl Forte®) and oral iron sulphate (Duroferon®) to blood donors
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Schneider, Uppsala University Hospital
- Investigators
- Norbert Lubenow, PhD, Principal investigator, Clinical Immunology and Transfusion Medicine Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678647
- Sponsor's protocol ID
- FOU2022-00167 980506
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be shared.
Publications
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.
PubMed 30287781Fabiano 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.
PubMed 30213039Birgegard 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.
PubMed 20598107Pisani 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.
PubMed 25395392Tolkien 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.
PubMed 25700159
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Comparative Trial of Oral Sucrosomial Iron (SiderAl Forte®) and Oral Iron Sulphate (Duroferon®) to Blood Donors.
- ClinicalTrials.gov ID
- NCT05678647
- Acronym / sponsor ID
- FOU2022-00167 980506
- Conditions
- Blood Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Drugs: Oral sucrosomial Iron (SiderAl Forte®) and oral iron sulphate (Duroferon®) to blood donors
| Arm | Type | Receives |
|---|---|---|
| Oral sucrosomial Iron (SiderAl Forte®) | Experimental | Drug: Sucrosomial IronOral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation |
| Oral iron sulphate (Duroferon®) | Active comparator | Drug: Iron SulfateOral iron sulphate (Duroferon®) is given to blood donors after blood donation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.
Key exclusion criteria (1 listed)
- Donors who cannot be accepted for blood donation anymore because they do not fulfill the Swedish criteria for blood donation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrosomial IronAlso: SiderAl Forte®20 capsules of Sucrosomial Iron 30 mg is given after blood donation | Drug | Oral sucrosomial Iron (SiderAl Forte®) |
| Iron SulfateAlso: Duroferon®20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation | Drug | Oral iron sulphate (Duroferon®) |
Primary outcome
Side effects
Time frame: One year
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.
2 secondary outcomes
Symptoms
Time frame: One year
Iron balance
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 30287781Gomez-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.
- Background: PubMed 30213039Fabiano 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.
- Background: PubMed 20598107Birgegard 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.
- Background: PubMed 25395392Pisani 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.
- Background: PubMed 25700159Tolkien 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.
- Individual participant dataSharing planned: No. Only aggregated data will be shared.
Related trials for Blood Donation
Active, not recruitingPhase 2
Treatment of Hemochromatosis
Hemochromatosis
RecruitingObservational study
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Healthy Volunteer
Not yet recruiting
Cookies for Platelets
Blood Donation
RecruitingPhase 2/3
Autologous Cold-stored Apheresis Platelets
Bleeding, Platelets
RecruitingPhase 4
Improving White Blood Cell Collection From Healthy Donors
Allogeneic Granulocyte Donation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Lubenow, PhD principal investigator
Clinical Immunology and Transfusion Medicine Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrosomial Iron and Iron Sulfate in people with Blood Donation, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678647, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.