Iron-deficiencyNCT04250298
Sucrosom5al Iron Supplementation in Blood Donors
A study testing sucrosomial iron in people with Iron-deficiency, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomial iron preparation in whole blood donors with iron deficiency for three months. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- sucrosomial iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 13 Nov 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deferral from donation because of low capillary hemoglobin (Hb) <12.5 g/dl (women) and Hb <13 g/dl;
- Otherwise eligibility for donation according to medical history;
- Ferritin at the time of deferral <30 ng/ml;
- Last whole blood donation >2 months prior to current hemoglobin level;
- Written informed consent;
- Venous Hb <12.5 g/dl (females) and <13.5 g/dl (men);
Who cannot join
- Lack of legal capacity or court-appointed representation;
- Known pregnancy;
- Lactation period;
- Chronic diarrhea or known inclination for diarrhea;
- Known or suspected fructose intolerance;
- iron supplementation during the last three months;
Show all 16Show fewer
- continuous or expected blood loss (capillary oozing);
- hypermenorrhea;
- planned surgical intervention with relevant blood loss within the next 3-4 months (duration of study);
- application of another iron supplementation during the next 3-4 months;
- intended application of preparations for a systematic increase of red blood cell and hemoglobin concentration or production (e.g. erythropoietin preparations, packed red blood cells) for the duration of the study;
- parallel participation in another clinical trial with insurance coverage;
- foreseeable compliance issues;
- foreseeable unavailability for the time of the final examination;
- Incompatibility with any of the ingredients of the product;
- Anemia requiring acute therapy: Hb <8g/dl (as indication of an obligatory correction of the hemoglobin level to a clinically irrelevant or non-therapeutic value);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Gain First Indications for the Impact of a Three-month's Oral Intake of an Iron Supplement With High Bioavailability on the Hemoglobin Concentration in Iron Deficient Blood Donors
The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomial iron preparation in whole blood donors with iron deficiency for three months.
Read the detailed description
In this academic, monocentric interventional pilot study with one cohorte, otherwise healthy blood donors who have been rejected from blood donation due to low hemoglobin (females <12.5 g/dl, males <13.5 g/dl) and low ferritin levels (<30 ng/ml) receive an iron-containing dietary supplement (sucrosomial iron) for three months with a daily intake of 30 g iron.
Fifty donors will be included in the study. The study population will consist of two sub-groups (premenopausal women and postmenopausal women plus men).
Our aim is to
- gain first findings concerning the extent of the change primarily in hemoglobin and secondly in ferritin concentrations
- observe acceptance and tolerance after intake of the test product for several months
- create pilot data for a following randomized controlled study.
In addition, possible clinical symptoms associated with iron deficiency will be recorded by using appropriate questionnaires (Questionnaire on the assessment of health-related quality of life [WHOQOL-Bref], Fatigue assessment questionnaire [FAQ], questionnaire on psychic symptoms of insomnia [RIS] and Restless Legs Syndrome).
- Conditions
- Iron-deficiency
- Being tested
- sucrosomial iron
- Keywords
- blood donors, donor rejection, sucrosomial iron, dietary supplements
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucrosomial ironDietary supplement
Also called OLEOvital(R) EISEN FORTE
oral intake of iron as sachets or capsules
| Study group | Role | What they receive |
|---|---|---|
| Iron deficient blood donors | Other | Daily intake of 30 mg of sucrosomial iron during 90-120 days (male and female whole blood donors) Receives: Dietary Supplement: sucrosomial iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb (g/dl) at E2
hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 90-120 days)
Measured: 90-120 days
Δ Hb (g/dl) (E2-E1)
Change of hemoglobin between visit 1 (E1, baseline ) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Measured: 90-120 days
Δ Hb (g/dl) (E2-E1) / 90 Days
Change of hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution interpolated to 90 days
Measured: 90 days
Δ Hb (g/dl) (E2-E1)* Ratio
Change of hemoglobin ratio of prescribed/taken iron supplementation/ 90 days (E1, baseline; E2, after 90-120 days) For practical reasons, the period between the first and the second examination and thus the duration of iron intake varied from 90 to 120 days. Therefore, as a result, all outcomes were standardized ot 90 days by interpolation
Measured: 90 days
Δ Response 1
Change of Hb between examination 1 and examination 2 /90 days ≥1.0 g/dl [yes/no] --> The number of subjects in whom the Hb value improved by at least 1 g/dl between E1 (baseline) and E2 (after 90-120 days, following iron supplementation intake)
Measured: 90 days
Δ Response 2
Change of Hb between examination 1 and examination 2 /90 days ≥1.5 g/dl [yes/no] --> The number of subjects in whom the Hb value improved by at least 1.5 g/dl between E1 (baseline) and E2 (after 90-120 days of iron supplementation intake)
Measured: 90 days
Δ Response 3
Change of Hb between examination 1 and examination 2 (E2)/90 days ≥2.0 g/dl [yes/no] --> The number of subjects in whom the Hb value improved by at least 2 g/dl between E1 (baseline) and E2 (after 90-120 days of iron supplementation intake)
Measured: 90 days
Ferritin (ng/ml) at E2
Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)
Measured: 90-120 days
Δ Ferritin (ng/ml) (E2-E1)
Change of Hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Measured: 90-120 days
Δ Ferritin (ng/ml) (E2-E1) / 90 Days
Change of ferritin between examination 1 (E1, baseline ) to examination 2 (E2, after 90-120 days) interpolated to 90 days
Measured: 90 days
Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 90 Days
Difference of ferritin values in ng/ml by comparing levels at baseline and 90-120 days after iron supplementation (interpolated to 90 days) A positive value for mean is considered an improvement.
Measured: 90 days
Intake Evaluation
Evaluation of the intake of sucrosomial iron [problem-free yes/no] --> The number of participants who reported problems with the intake of the iron sachets
Measured: 90-120 days
Problems With Intake
The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.
Measured: 90-120 days
Recommendation
Will use of sucrosomial iron for other blood donors be recommended [yes/no] --> The number refers to the number of participants who would recommend taking the product to others.
Measured: day 90-120
Renewed Intake
Will sucrosomial iron will be taken again in the given case
Measured: day 90-120
Assumed Adverse Effects
Assumed test product adverse effects
Measured: 90-120 days
Quality of Life by World Health Organization Quality of Life Assessment (E2)
Assessment of Scores at E2 after 90-120 days of iron intake. The WHOQOL-Bref includes 26 items with values of 1-5 addressing 4 domains (neg. phrased items are reversed for analysis.) Higher scores denote a higher quality of life, but there are no cut-off points above or below which quality of life could be evaluated as poor or good.
Physical health: 7 items (4-20) Psychic health: 6 items (4-20) Social relationships: 3 items (4-20) Environment: 8 items (4-20) Score calculation: Domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life (without adjusting to WHOQOL-100).
Conversion to the final score (summarizing all 4 domains) was not performed (only the differences between E1 and E2 were of interest).
Measured: 14 days
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2)
Differences in the WHOQOL BREF categories between E1 (baseline) and E2 (after 90-120 days of iron intake).
The WHOQOL-Bref includes 26 items with values of 1-5 addressing 4 domains (neg. phrased items are reversed for analysis.) Higher scores denote a higher quality of life, but there are no cut-off points above or below which quality of life could be evaluated as poor or good.
Physical health: 7 items (4-20) Psychic health: 6 items (4-20) Social relationships: 3 items (4-20) Environment: 8 items (4-20) Score calculation: Domain and facet scores are scaled in a positive direction where higher scores denote higer qualitiy of life (without adjusting to WHOQOL-100).
Conversion to the final score (summarizing all 4 domains) was not performed (only the differences between E1 and E2 were of interest).
Measured: 90-120 days
Fatigue Assessment Questionnaire (E2)
Assessment of the score at E2 (after 90-120 days of iron intake). The Fatigue Assessment Questionnaire (FAQ) is a 20-item self-report scale evaluating symptoms of chronic fatigue. Values range from 0-3. The total score ranges from 0 to 60, with a higher score indicating more severe fatigue.
The answers to the questions had to refer to the past week in accordance with the FAQ guidelines, so 7 days was given as the outcome measure time frame.
The mean with confidence interval (95%) for fatigue at E2 is shown here.
Measured: 7 days
Δ Fatigue Assessment Questionnaire (E1-E2)
In the Fatigue Assessment Questionnaire (FAQ) fatigue was determined at E1 and E2. The Fatigue Assessment Questionnaire (FAQ) is a 20-item self-report scale evaluating symptoms of chronic fatigue. Values range from 0-3. The total score ranges from 0 to 60, with a higher score indicating more severe fatigue. In this outcome the change of fatigue between examination 1 (E1, baseline) and examination 2 (after 90-120 days of iron intake) was determined.
The answers to the questions had to refer to the past week in accordance with the FAQ guidelines, so 7 days was given as the outcome measure time frame.
The number of subjects with fatigue before and after the intervention was analysed. A reduction in the number is considered an improvement.
The mean (difference) with confidence interval (95%) for fatigue (E1-E2) is shown here.
Measured: 7 days
Regensburg Insomnia Scale at E2
Symptoms of insomnia were determined at examination 2 after 90-120 days of iron intake. The questionnaire consists of 10 items with values of 0-4. Total scores range from 0 to 40 points with higher scores indicative of more psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are an indication of symptoms associated with insomnia.
The questions in the questionnaire relate to the last 4 weeks, so the time of the results measurement was set at 28 days.
The mean with confidence interval (95%) for insomnia at E2 is shown here.
Measured: 28 days
Δ Regensburg Insomnia Scale (E1-E2)
Change of symptoms of insomnia between examination 1 and examination 2. Symptoms of insomnia (Regensburg Insomnia Scale) were determined at examination 1 and 2. In this outcome the difference between E1 (baseline) and E2 (after 90-120 days of iron intake) was determined.
The questionnaire consists of 10 items with values of 0-4. Total scores range from 0 to 40 points with higher scores indicative of more psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are an indication of symptoms associated with insomnia. A reduction in the score between E1 and E2 is considered an improvement in sleep.
The mean (difference) with confidence interval (95%) for insomnia (E1-E2) is shown here.
Measured: 90-120 days
Secondary outcomes (5)
Restless Legs Syndrome at E1
The number of participants suffering from restless legs syndrome at baseline (E1)
Measured: 90-120 days
Restless Legs Syndrome at E2
The number of participants suffering from restless legs syndrome at baseline (E2)
Measured: 90-120 days
Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]
The number of participants who experienced diarrhoea during iron intake in days
Measured: 90-120 days
Clinical Symptoms of Iron Deficiency E1
Clinical symptoms of iron deficiency at baseline (E1), numbers discribe the count of participants affected.
Measured: 90-120 days
Clinical Symptoms of Iron Deficiency E2
Clinical symptoms of iron deficiency at baseline (E2), numbers discribe the count of participants affected.
Measured: 90-120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start13 Nov 2019
- Primary completion28 Sep 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This monocentric study (single cohort study design) is classified as a food study (application of the commercially available supplement OLEOvital® EISEN FORTE) in an interventional setting (study-related measures: additional blood tests and oral intake of OLEOvital® EISEN FORTE).
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Kepler University of Linz, Fresenius Kabi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250298
- Sponsor's protocol ID
- 31-435 ex 18/19
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2020
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.
PubMed 25469720Finch CA, Cook JD, Labbe RF, Culala M. Effect of blood donation on iron stores as evaluated by serum ferritin. Blood. 1977 Sep;50(3):441-7.
PubMed 884321Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Vij V, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II. Iron deficiency in blood donors: analysis of enrollment data from the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2011 Mar;51(3):511-22. doi: 10.1111/j.1537-2995.2010.02865.x. Epub 2010 Aug 30.
PubMed 20804527Rigas AS, Sorensen CJ, Pedersen OB, Petersen MS, Thorner LW, Kotze S, Sorensen E, Magnussen K, Rostgaard K, Erikstrup C, Ullum H. Predictors of iron levels in 14,737 Danish blood donors: results from the Danish Blood Donor Study. Transfusion. 2014 Mar;54(3 Pt 2):789-96. doi: 10.1111/trf.12518. Epub 2013 Dec 23.
PubMed 24372094Conrad ME, Crosby WH, Jacobs A, Kaltwasser JP, Nusbacher J. The Hippocratian principle of 'primum nil nocere' demands that the metabolic state of a donor should be normalized prior to a subsequent donation of blood or plasma. How much blood, relative to his body weight, can a donor give over a certain period, without a continuous deviation of iron metabolism in the direction of iron deficiency? Vox Sang. 1981 Nov-Dec;41(5-6):336-43. doi: 10.1111/j.1423-0410.1981.tb01059.x. No abstract available.
PubMed 7324448Bianco C, Brittenham G, Gilcher RO, Gordeuk VR, Kushner JP, Sayers M, Chambers L, Counts RB, Aylesworth C, Nemo G, Alving B. Maintaining iron balance in women blood donors of childbearing age: summary of a workshop. Transfusion. 2002 Jun;42(6):798-805. doi: 10.1046/j.1537-2995.2002.00103.x. No abstract available.
PubMed 12147035Cable RG, Brambilla D, Glynn SA, Kleinman S, Mast AE, Spencer BR, Stone M, Kiss JE; National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Effect of iron supplementation on iron stores and total body iron after whole blood donation. Transfusion. 2016 Aug;56(8):2005-12. doi: 10.1111/trf.13659. Epub 2016 May 27.
PubMed 27232535Kiss JE, Brambilla D, Glynn SA, Mast AE, Spencer BR, Stone M, Kleinman SH, Cable RG; National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Oral iron supplementation after blood donation: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):575-83. doi: 10.1001/jama.2015.119.
PubMed 25668261Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
PubMed 26289639Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
PubMed 29032957Pisani 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 25395392Parisi F, Berti C, Mando C, Martinelli A, Mazzali C, Cetin I. Effects of different regimens of iron prophylaxis on maternal iron status and pregnancy outcome: a randomized control trial. J Matern Fetal Neonatal Med. 2017 Aug;30(15):1787-1792. doi: 10.1080/14767058.2016.1224841. Epub 2016 Sep 2.
PubMed 27588568Spencer BR, Kleinman S, Wright DJ, Glynn SA, Rye DB, Kiss JE, Mast AE, Cable RG; REDS-II RISE Analysis Group. Restless legs syndrome, pica, and iron status in blood donors. Transfusion. 2013 Aug;53(8):1645-52. doi: 10.1111/trf.12260. Epub 2013 Jun 13.
PubMed 23763445Verdon F, Burnand B, Stubi CL, Bonard C, Graff M, Michaud A, Bischoff T, de Vevey M, Studer JP, Herzig L, Chapuis C, Tissot J, Pecoud A, Favrat B. Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomised placebo controlled trial. BMJ. 2003 May 24;326(7399):1124. doi: 10.1136/bmj.326.7399.1124.
PubMed 12763985Brownlie T 4th, Utermohlen V, Hinton PS, Haas JD. Tissue iron deficiency without anemia impairs adaptation in endurance capacity after aerobic training in previously untrained women. Am J Clin Nutr. 2004 Mar;79(3):437-43. doi: 10.1093/ajcn/79.3.437.
PubMed 14985219
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Gain First Indications for the Impact of a Three-month's Oral Intake of an Iron Supplement With High Bioavailability on the Hemoglobin Concentration in Iron Deficient Blood Donors
- ClinicalTrials.gov ID
- NCT04250298
- Acronym / sponsor ID
- 31-435 ex 18/19
- Conditions
- Iron-deficiency
- Keywords
- blood donors, donor rejection, sucrosomial iron, dietary supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Johannes Kepler University of Linz, Fresenius Kabi
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomial iron preparation in whole blood donors with iron deficiency for three months.
Detailed description
In this academic, monocentric interventional pilot study with one cohorte, otherwise healthy blood donors who have been rejected from blood donation due to low hemoglobin (females <12.5 g/dl, males <13.5 g/dl) and low ferritin levels (<30 ng/ml) receive an iron-containing dietary supplement (sucrosomial iron) for three months with a daily intake of 30 g iron.
Fifty donors will be included in the study. The study population will consist of two sub-groups (premenopausal women and postmenopausal women plus men).
Our aim is to
- gain first findings concerning the extent of the change primarily in hemoglobin and secondly in ferritin concentrations
- observe acceptance and tolerance after intake of the test product for several months
- create pilot data for a following randomized controlled study.
In addition, possible clinical symptoms associated with iron deficiency will be recorded by using appropriate questionnaires (Questionnaire on the assessment of health-related quality of life [WHOQOL-Bref], Fatigue assessment questionnaire [FAQ], questionnaire on psychic symptoms of insomnia [RIS] and Restless Legs Syndrome).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This monocentric study (single cohort study design) is classified as a food study (application of the commercially available supplement OLEOvital® EISEN FORTE) in an interventional setting (study-related measures: additional blood tests and oral intake of OLEOvital® EISEN FORTE).
| Arm | Type | Receives |
|---|---|---|
| Iron deficient blood donors | Other | Dietary Supplement: sucrosomial ironDaily intake of 30 mg of sucrosomial iron during 90-120 days (male and female whole blood donors) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Deferral from donation because of low capillary hemoglobin (Hb) <12.5 g/dl (women) and Hb <13 g/dl;
- Otherwise eligibility for donation according to medical history;
- Ferritin at the time of deferral <30 ng/ml;
- Last whole blood donation >2 months prior to current hemoglobin level;
- Written informed consent;
Key exclusion criteria (16 listed)
- Lack of legal capacity or court-appointed representation;
- Known pregnancy;
- Lactation period;
- Chronic diarrhea or known inclination for diarrhea;
- Known or suspected fructose intolerance;
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: OLEOvital(R) EISEN FORTEoral intake of iron as sachets or capsules | Dietary supplement | Iron deficient blood donors |
Primary outcome
Hb (g/dl) at E2
Time frame: 90-120 days
hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 90-120 days)
Δ Hb (g/dl) (E2-E1)
Time frame: 90-120 days
Change of hemoglobin between visit 1 (E1, baseline ) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Δ Hb (g/dl) (E2-E1) / 90 Days
Time frame: 90 days
Change of hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution interpolated to 90 days
Δ Hb (g/dl) (E2-E1)* Ratio
Time frame: 90 days
Change of hemoglobin ratio of prescribed/taken iron supplementation/ 90 days (E1, baseline; E2, after 90-120 days) For practical reasons, the period between the first and the second examination and thus the duration of iron intake varied from 90 to 120 days. Therefore, as a result, all outcomes were standardized ot 90 days by interpolation
Δ Response 1
Time frame: 90 days
Change of Hb between examination 1 and examination 2 /90 days ≥1.0 g/dl [yes/no] --> The number of subjects in whom the Hb value improved by at least 1 g/dl between E1 (baseline) and E2 (after 90-120 days, following iron supplementation intake)
Δ Response 2
Time frame: 90 days
Change of Hb between examination 1 and examination 2 /90 days ≥1.5 g/dl [yes/no] --> The number of subjects in whom the Hb value improved by at least 1.5 g/dl between E1 (baseline) and E2 (after 90-120 days of iron supplementation intake)
Δ Response 3
Time frame: 90 days
Change of Hb between examination 1 and examination 2 (E2)/90 days ≥2.0 g/dl [yes/no] --> The number of subjects in whom the Hb value improved by at least 2 g/dl between E1 (baseline) and E2 (after 90-120 days of iron supplementation intake)
Ferritin (ng/ml) at E2
Time frame: 90-120 days
Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)
Δ Ferritin (ng/ml) (E2-E1)
Time frame: 90-120 days
Change of Hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Δ Ferritin (ng/ml) (E2-E1) / 90 Days
Time frame: 90 days
Change of ferritin between examination 1 (E1, baseline ) to examination 2 (E2, after 90-120 days) interpolated to 90 days
Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 90 Days
Time frame: 90 days
Difference of ferritin values in ng/ml by comparing levels at baseline and 90-120 days after iron supplementation (interpolated to 90 days) A positive value for mean is considered an improvement.
Intake Evaluation
Time frame: 90-120 days
Evaluation of the intake of sucrosomial iron [problem-free yes/no] --> The number of participants who reported problems with the intake of the iron sachets
Problems With Intake
Time frame: 90-120 days
The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.
Recommendation
Time frame: day 90-120
Will use of sucrosomial iron for other blood donors be recommended [yes/no] --> The number refers to the number of participants who would recommend taking the product to others.
Renewed Intake
Time frame: day 90-120
Will sucrosomial iron will be taken again in the given case
Assumed Adverse Effects
Time frame: 90-120 days
Assumed test product adverse effects
Quality of Life by World Health Organization Quality of Life Assessment (E2)
Time frame: 14 days
Assessment of Scores at E2 after 90-120 days of iron intake. The WHOQOL-Bref includes 26 items with values of 1-5 addressing 4 domains (neg. phrased items are reversed for analysis.) Higher scores denote a higher quality of life, but there are no cut-off points above or below which quality of life could be evaluated as poor or good. Physical health: 7 items (4-20) Psychic health: 6 items (4-20) Social relationships: 3 items (4-20) Environment: 8 items (4-20) Score calculation: Domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life (without adjusting to WHOQOL-100). Conversion to the final score (summarizing all 4 domains) was not performed (only the differences between E1 and E2 were of interest).
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2)
Time frame: 90-120 days
Differences in the WHOQOL BREF categories between E1 (baseline) and E2 (after 90-120 days of iron intake). The WHOQOL-Bref includes 26 items with values of 1-5 addressing 4 domains (neg. phrased items are reversed for analysis.) Higher scores denote a higher quality of life, but there are no cut-off points above or below which quality of life could be evaluated as poor or good. Physical health: 7 items (4-20) Psychic health: 6 items (4-20) Social relationships: 3 items (4-20) Environment: 8 items (4-20) Score calculation: Domain and facet scores are scaled in a positive direction where higher scores denote higer qualitiy of life (without adjusting to WHOQOL-100). Conversion to the final score (summarizing all 4 domains) was not performed (only the differences between E1 and E2 were of interest).
Fatigue Assessment Questionnaire (E2)
Time frame: 7 days
Assessment of the score at E2 (after 90-120 days of iron intake). The Fatigue Assessment Questionnaire (FAQ) is a 20-item self-report scale evaluating symptoms of chronic fatigue. Values range from 0-3. The total score ranges from 0 to 60, with a higher score indicating more severe fatigue. The answers to the questions had to refer to the past week in accordance with the FAQ guidelines, so 7 days was given as the outcome measure time frame. The mean with confidence interval (95%) for fatigue at E2 is shown here.
Δ Fatigue Assessment Questionnaire (E1-E2)
Time frame: 7 days
In the Fatigue Assessment Questionnaire (FAQ) fatigue was determined at E1 and E2. The Fatigue Assessment Questionnaire (FAQ) is a 20-item self-report scale evaluating symptoms of chronic fatigue. Values range from 0-3. The total score ranges from 0 to 60, with a higher score indicating more severe fatigue. In this outcome the change of fatigue between examination 1 (E1, baseline) and examination 2 (after 90-120 days of iron intake) was determined. The answers to the questions had to refer to the past week in accordance with the FAQ guidelines, so 7 days was given as the outcome measure time frame. The number of subjects with fatigue before and after the intervention was analysed. A reduction in the number is considered an improvement. The mean (difference) with confidence interval (95%) for fatigue (E1-E2) is shown here.
Regensburg Insomnia Scale at E2
Time frame: 28 days
Symptoms of insomnia were determined at examination 2 after 90-120 days of iron intake. The questionnaire consists of 10 items with values of 0-4. Total scores range from 0 to 40 points with higher scores indicative of more psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are an indication of symptoms associated with insomnia. The questions in the questionnaire relate to the last 4 weeks, so the time of the results measurement was set at 28 days. The mean with confidence interval (95%) for insomnia at E2 is shown here.
Δ Regensburg Insomnia Scale (E1-E2)
Time frame: 90-120 days
Change of symptoms of insomnia between examination 1 and examination 2. Symptoms of insomnia (Regensburg Insomnia Scale) were determined at examination 1 and 2. In this outcome the difference between E1 (baseline) and E2 (after 90-120 days of iron intake) was determined. The questionnaire consists of 10 items with values of 0-4. Total scores range from 0 to 40 points with higher scores indicative of more psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are an indication of symptoms associated with insomnia. A reduction in the score between E1 and E2 is considered an improvement in sleep. The mean (difference) with confidence interval (95%) for insomnia (E1-E2) is shown here.
5 secondary outcomes
Restless Legs Syndrome at E1
Time frame: 90-120 days
Restless Legs Syndrome at E2
Time frame: 90-120 days
Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]
Time frame: 90-120 days
Clinical Symptoms of Iron Deficiency E1
Time frame: 90-120 days
Clinical Symptoms of Iron Deficiency E2
Time frame: 90-120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25469720Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.
- Background: PubMed 884321Finch CA, Cook JD, Labbe RF, Culala M. Effect of blood donation on iron stores as evaluated by serum ferritin. Blood. 1977 Sep;50(3):441-7.
- Background: PubMed 20804527Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Vij V, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II. Iron deficiency in blood donors: analysis of enrollment data from the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2011 Mar;51(3):511-22. doi: 10.1111/j.1537-2995.2010.02865.x. Epub 2010 Aug 30.
- Background: PubMed 24372094Rigas AS, Sorensen CJ, Pedersen OB, Petersen MS, Thorner LW, Kotze S, Sorensen E, Magnussen K, Rostgaard K, Erikstrup C, Ullum H. Predictors of iron levels in 14,737 Danish blood donors: results from the Danish Blood Donor Study. Transfusion. 2014 Mar;54(3 Pt 2):789-96. doi: 10.1111/trf.12518. Epub 2013 Dec 23.
- Background: PubMed 7324448Conrad ME, Crosby WH, Jacobs A, Kaltwasser JP, Nusbacher J. The Hippocratian principle of 'primum nil nocere' demands that the metabolic state of a donor should be normalized prior to a subsequent donation of blood or plasma. How much blood, relative to his body weight, can a donor give over a certain period, without a continuous deviation of iron metabolism in the direction of iron deficiency? Vox Sang. 1981 Nov-Dec;41(5-6):336-43. doi: 10.1111/j.1423-0410.1981.tb01059.x. No abstract available.
- Background: PubMed 12147035Bianco C, Brittenham G, Gilcher RO, Gordeuk VR, Kushner JP, Sayers M, Chambers L, Counts RB, Aylesworth C, Nemo G, Alving B. Maintaining iron balance in women blood donors of childbearing age: summary of a workshop. Transfusion. 2002 Jun;42(6):798-805. doi: 10.1046/j.1537-2995.2002.00103.x. No abstract available.
- Background: PubMed 27232535Cable RG, Brambilla D, Glynn SA, Kleinman S, Mast AE, Spencer BR, Stone M, Kiss JE; National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Effect of iron supplementation on iron stores and total body iron after whole blood donation. Transfusion. 2016 Aug;56(8):2005-12. doi: 10.1111/trf.13659. Epub 2016 May 27.
- Background: PubMed 25668261Kiss JE, Brambilla D, Glynn SA, Mast AE, Spencer BR, Stone M, Kleinman SH, Cable RG; National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Oral iron supplementation after blood donation: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):575-83. doi: 10.1001/jama.2015.119.
- Background: PubMed 26289639Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
- Background: PubMed 29032957Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.
- 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 27588568Parisi F, Berti C, Mando C, Martinelli A, Mazzali C, Cetin I. Effects of different regimens of iron prophylaxis on maternal iron status and pregnancy outcome: a randomized control trial. J Matern Fetal Neonatal Med. 2017 Aug;30(15):1787-1792. doi: 10.1080/14767058.2016.1224841. Epub 2016 Sep 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Iron-deficiency, run by Medical University of Graz at 1 site in Austria.
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 6 inclusion and 16 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 16 Sep 2025. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hb (g/dl) at E2 (time frame: 90-120 days). The study lists 22 primary outcomes in all. 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 NCT04250298, which also lists 19 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 16 Sep 2025.