Sucrosom5al Iron Supplementation in Blood Donors

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Dietary supplement: sucrosomial iron

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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;
• 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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Iron deficient blood donors; Daily intake of 30 mg of sucrosomial iron during 90-120 days (male and female whole blood donors)	Dietary supplement: sucrosomial iron; oral intake of iron as sachets or capsules; Other Names: OLEOvital(R) EISEN FORTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hb (g/dl) at E2	hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 90-120 days)	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	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	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	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)	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)	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)	90 days
Ferritin (ng/ml) at E2	Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)	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	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	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.	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	90-120 days
Problems With Intake	The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.	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.	day 90-120
Renewed Intake	Will sucrosomial iron will be taken again in the given case	day 90-120
Assumed Adverse Effects	Assumed test product adverse effects	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).	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).	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.	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.	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.	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.	90-120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restless Legs Syndrome at E1	The number of participants suffering from restless legs syndrome at baseline (E1)	90-120 days
Restless Legs Syndrome at E2	The number of participants suffering from restless legs syndrome at baseline (E2)	90-120 days
Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]	The number of participants who experienced diarrhoea during iron intake in days	90-120 days
Clinical Symptoms of Iron Deficiency E1	Clinical symptoms of iron deficiency at baseline (E1), numbers discribe the count of participants affected.	90-120 days
Clinical Symptoms of Iron Deficiency E2	Clinical symptoms of iron deficiency at baseline (E2), numbers discribe the count of participants affected.	90-120 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Sex [female/male]	day 1
SAE	Serious adverse events [categories by dype and duration]	90-120 days
Hb at E1	Hemoglobin at examination 1 (E1, baseline)	day 1
Regensburg Insomnia Scale at E1	Symptoms of insomnia at examination 1 (E1, baseline) Symptoms of insomnia were determined at E 1 prior iron intake (baseline). 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 E1 is shown here.	28 days
RLS at E1	Restless legs syndrome at examination 1 (E1, baseline) [yes/no]	day 1
Age at E1	Age at examination 1 (E1, baseline) [years]	day 1
Body Weight	Body weight at examination 1 (E1, baseline) [kg]	day 1
Body Heights	Body heights at examination 1 (E1, baseline) [cm]	day 1
BMI	Body mass index at examination 1 (E1, baseline)	day 1
Intake of Sucrosomial Iron I	Participants could choose between sachets or capsules	day 1
Intake Number	Number of sachets or capsules (one per day) taken at E2 (after 90-120 days) [number]	day 90-120
Intake Ratio	Ratio of ingested to prescribed capsules	day 90-120
No Intake	days of violation of the intake rules [days], where iron was not taken during the study interval	day 90-120
Number of Participants Who Met Drop Out Criteria	Drop out criteria [categories] occuring during the study interval (between E1 and E2)	between E1 and E2
Relevant Pre-existing Conditions	relevant already cured pre-existing conditions [categories by type] prior to study begin	day 1
Last Menstrual Period I	Time interval between the end of the last menstrual period and blood collection for examination 1 (baseline) [days]	0-90 days
Last Menstrual Period II	Time interval between the end of the last menstrual period up to examination 2 (end of study interval after iron intake) [days]	90-120 days
Last Menstrual Period III	Count of menstrual bleedings between blood tests (during study interval) [number]	90-120 days

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Johannes Kepler University of Linz; Fresenius Kabi

Publications and helpful links

General Publications

• Bianco 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.
• Verdon 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.
• 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.
• Finch 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.
• Cable 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.
• Rigas 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.
• Conrad 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.
• Cable 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.
• Kiss 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.
• Moretti 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.
• Stoffel 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.
• 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.
• Parisi 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.
• Spencer 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.
• Brownlie 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.
• Murray-Kolb LE, Beard JL. Iron treatment normalizes cognitive functioning in young women. Am J Clin Nutr. 2007 Mar;85(3):778-87. doi: 10.1093/ajcn/85.3.778.
• Moeinvaziri M, Mansoori P, Holakooee K, Safaee Naraghi Z, Abbasi A. Iron status in diffuse telogen hair loss among women. Acta Dermatovenerol Croat. 2009;17(4):279-84.
• Chansky MC, King MR, Bialkowski W, Bryant BJ, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Mast AE. Qualitative assessment of pica experienced by frequent blood donors. Transfusion. 2017 Apr;57(4):946-951. doi: 10.1111/trf.13981. Epub 2017 Feb 5.
• Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003 Mar;4(2):101-19. doi: 10.1016/s1389-9457(03)00010-8.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: dietary supplements; blood donors; donor rejection; sucrosomial iron
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Nutritional and Metabolic Diseases; Iron Deficiencies; sucrosomial iron
• Other Study ID Numbers: 31-435 ex 18/19

Drug and device information, study documents

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