Sucrosom5al Iron Supplementation in Blood Donors

NCT04250298 | Completed Results

• 1 other identifier: 31-435 ex 18/19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-deficiency

Keywords

blood donors; donor rejection; sucrosomial iron; dietary supplements

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (5)

• Restless Legs Syndrome at E1

  90-120 days

• Restless Legs Syndrome at E2

  90-120 days

• Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]

  90-120 days

• Clinical Symptoms of Iron Deficiency E1

  90-120 days

• Clinical Symptoms of Iron Deficiency E2

  90-120 days

Other Outcomes (18)

• Hb at E1

  day 1

• Regensburg Insomnia Scale at E1

  28 days

• RLS at E1

  day 1

Study Arms (1)

Iron deficient blood donors

OTHER

Daily intake of 30 mg of sucrosomial iron during 90-120 days (male and female whole blood donors)

Dietary Supplement: sucrosomial iron

Interventions

sucrosomial iron DIETARY_SUPPLEMENT

oral intake of iron as sachets or capsules

Also known as: OLEOvital(R) EISEN FORTE

Iron deficient blood donors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medical University of Graz: lead
• Johannes Kepler University of Linz: collaborator
• Fresenius Kabi: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (19)

• 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.

  PMID: 25469720 BACKGROUND

• 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.

  PMID: 884321 BACKGROUND

• 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.

  PMID: 20804527 BACKGROUND

• 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.

  PMID: 24372094 BACKGROUND

• 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.

  PMID: 7324448 BACKGROUND

• 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.

  PMID: 12147035 BACKGROUND

• 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.

  PMID: 27232535 BACKGROUND

• 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.

  PMID: 25668261 BACKGROUND

• 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.

  PMID: 26289639 BACKGROUND

• 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.

  PMID: 29032957 BACKGROUND

• 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: 25395392 BACKGROUND

• 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.

  PMID: 27588568 BACKGROUND

• 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.

  PMID: 23763445 BACKGROUND

• 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.

  PMID: 12763985 BACKGROUND

• 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.

  PMID: 14985219 BACKGROUND

• 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.

  PMID: 17344500 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 14592341 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

sucrosomial iron

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Single arm study without control group; small sample size

Results Point of Contact

• Title: Dr. Camilla Drexler-Helmberg
• Organization: Medical University Graz

camilla.drexler@uniklinikum.kages.at

0043316385

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 31, 2020
• Study Start: November 13, 2019
• Primary Completion: September 28, 2020
• Study Completion: December 20, 2020
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Locations

AU (1)