Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johannes Kepler University of Linz | OTHER |
| Fresenius Kabi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron deficient blood donors | Other | Daily intake of 30 mg of sucrosomial iron during 90-120 days (male and female whole blood donors) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sucrosomial iron | Dietary Supplement | oral intake of iron as sachets or capsules |
|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25469720 | Background | 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. | |
| 884321 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | The arm includes male and female whole blood donors who were deferred from blood donation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per protocol evaluation
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | The arm includes male and female whole blood donors who were deferred from blood donation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hb (g/dl) at E2 | hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 90-120 days) | 23 female, premenopausal 24 female, post menopausal or male | Posted | Mean | Standard Deviation | g/dl | 90-120 days |
|
|
Adverse events were queried at the second visit, i.e. 90-120 days after the first visit.
We used a food supplement in the dosage recommended by the manufacturer, already known to be well tolerated in (apart from iron deficiency) healthy blood donors. Therefore neither serious adverse events, nor a risk for all-cause mortality was expected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | The arm includes male and female whole blood donors who were deferred from blood donation. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleep | General disorders | Non-systematic Assessment | initially problems to fall asleep |
Single arm study without control group; small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Camilla Drexler-Helmberg | Medical University Graz | 0043316385 | 83066 | camilla.drexler@uniklinikum.kages.at |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2023 | Mar 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2023 | Feb 19, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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 |
| Sex | Sex [female/male] | 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 |
| SAE | Serious adverse events [categories by dype and duration] | 90-120 days |
| 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 |
| 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. |
| 20804527 | 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. |
| 24372094 | 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. |
| 7324448 | 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. |
| 12147035 | 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. |
| 27232535 | 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. |
| 25668261 | 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. |
| 26289639 | 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. |
| 29032957 | 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. |
| 25395392 | 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. |
| 27588568 | 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. |
| 23763445 | 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. |
| 12763985 | 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. |
| 14985219 | 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. |
| 17344500 | 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. |
| 20021982 | 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. |
| 28164344 | Background | 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. |
| 14592341 | Background | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin | Median | Inter-Quartile Range | g/dl |
|
| Ferritin | Median | Inter-Quartile Range | ng/ml |
|
|
|
| Primary | 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 | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | Standard Deviation | g/dl | 90-120 days |
|
|
|
|
| Primary | 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 | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | Standard Error | g/dl | 90 days |
|
|
|
|
| Primary | 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 | 23 premenopausal, female 24 postmenopausal, female or men | Posted | Median | Inter-Quartile Range | g/dl | 90 days |
|
|
|
|
| Primary | 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) | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | 90 days |
|
|
|
|
| Primary | 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) | 23 premenopausal female 24 postmenopausal, female, or male | Posted | Count of Participants | Participants | 90 days |
|
|
|
|
| Primary | 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) | 23 premenopausal, female 24 postmenopausal, female or male | Posted | Count of Participants | Participants | 90 days |
|
|
|
|
| Primary | Ferritin (ng/ml) at E2 | Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation) | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | Standard Deviation | ng/ml | 90-120 days |
|
|
|
|
| Primary | 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 | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | Standard Deviation | ng/ml | 90-120 days |
|
|
|
|
| Primary | 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 | 23 premenopausal women, 10 postmenopausal women and 14 men completed the study | Posted | Median | Inter-Quartile Range | ng/ml | 90 days |
|
|
|
|
| Primary | 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. | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | Standard Deviation | ng/ml | 90 days |
|
|
|
|
| Primary | 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 | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | 90-120 days |
|
|
|
| Primary | Problems With Intake | The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints. | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Number | participants | 90-120 days |
|
|
|
| Primary | 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. | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | day 90-120 |
|
|
|
| Primary | Renewed Intake | Will sucrosomial iron will be taken again in the given case | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | day 90-120 |
|
|
|
| Primary | Assumed Adverse Effects | Assumed test product adverse effects | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | 90-120 days |
|
|
|
| Primary | 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). | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | 95% Confidence Interval | Units on a scale | 14 days |
|
|
|
|
| Primary | 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). | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | 95% Confidence Interval | Units on a scale | 90-120 days |
|
|
|
| Primary | 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. | 23 female premenopausal 24 female postmenopausal or male | Posted | Mean | 95% Confidence Interval | Units on a scale | 7 days |
|
|
|
|
| Primary | 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. | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Mean | 95% Confidence Interval | Units on a scale | 7 days |
|
|
|
|
| Primary | 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. | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | 95% Confidence Interval | Units on a scale | 28 days |
|
|
|
|
| Primary | 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. | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | 95% Confidence Interval | Units on a scale | 90-120 days |
|
|
|
|
| Secondary | Restless Legs Syndrome at E1 | The number of participants suffering from restless legs syndrome at baseline (E1) | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | 90-120 days |
|
|
|
| Secondary | Restless Legs Syndrome at E2 | The number of participants suffering from restless legs syndrome at baseline (E2) | 23 female, premenopausal 24 female, postmenopausal or male | Posted | Count of Participants | Participants | 90-120 days |
|
|
|
| Secondary | Frequency of Diarrhoea During Sucrosomial Iron Intake [Days] | The number of participants who experienced diarrhoea during iron intake in days | 23 female premenopausal 24 female post menopausal or male | Posted | Count of Participants | Participants | 90-120 days |
|
|
|
| Secondary | Clinical Symptoms of Iron Deficiency E1 | Clinical symptoms of iron deficiency at baseline (E1), numbers discribe the count of participants affected. | 23 female premenopausal 24 female post menopausal or male | Posted | Number | participants | 90-120 days |
|
|
|
| Other Pre-specified | Hb at E1 | Hemoglobin at examination 1 (E1, baseline) | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | g/dl | day 1 |
|
|
|
|
| Other Pre-specified | 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. | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | 95% Confidence Interval | Units on a scale | 28 days |
|
|
|
|
| Other Pre-specified | RLS at E1 | Restless legs syndrome at examination 1 (E1, baseline) [yes/no] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Count of Participants | Participants | day 1 |
|
|
|
|
| Other Pre-specified | Age at E1 | Age at examination 1 (E1, baseline) [years] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | years | day 1 |
|
|
|
|
| Other Pre-specified | Sex | Sex [female/male] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Count of Participants | Participants | day 1 |
|
|
|
|
| Other Pre-specified | Body Weight | Body weight at examination 1 (E1, baseline) [kg] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | kg | day 1 |
|
|
|
|
| Other Pre-specified | Body Heights | Body heights at examination 1 (E1, baseline) [cm] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | cm | day 1 |
|
|
|
|
| Other Pre-specified | BMI | Body mass index at examination 1 (E1, baseline) | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | kg/m2 | day 1 |
|
|
|
|
| Other Pre-specified | Intake of Sucrosomial Iron I | Participants could choose between sachets or capsules | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Count of Participants | Participants | day 1 |
|
|
|
| Other Pre-specified | Intake Number | Number of sachets or capsules (one per day) taken at E2 (after 90-120 days) [number] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | capsules/sachets | day 90-120 |
|
|
|
| Other Pre-specified | Intake Ratio | Ratio of ingested to prescribed capsules | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | ratio | day 90-120 |
|
|
|
|
| Other Pre-specified | No Intake | days of violation of the intake rules [days], where iron was not taken during the study interval | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Mean | Standard Deviation | days | day 90-120 |
|
|
|
|
| Other Pre-specified | Number of Participants Who Met Drop Out Criteria | Drop out criteria [categories] occuring during the study interval (between E1 and E2) | 25 female, premenopausal 25 female, postmenopausal or men | Posted | Count of Participants | Participants | between E1 and E2 |
|
|
|
| Other Pre-specified | Relevant Pre-existing Conditions | relevant already cured pre-existing conditions [categories by type] prior to study begin | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Count of Participants | Participants | day 1 |
|
|
|
| Other Pre-specified | SAE | Serious adverse events [categories by dype and duration] | 23 female, premenopausal 24 female, postmenopausal or men | Posted | Count of Participants | Participants | 90-120 days |
|
|
|
| Other Pre-specified | Last Menstrual Period I | Time interval between the end of the last menstrual period and blood collection for examination 1 (baseline) [days] | 23 premenopausal, female | Posted | Mean | Standard Deviation | days | 0-90 days |
|
|
|
| Other Pre-specified | 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] | 23 female, premenopausal | Posted | Mean | Standard Deviation | days | 90-120 days |
|
|
|
| Other Pre-specified | Last Menstrual Period III | Count of menstrual bleedings between blood tests (during study interval) [number] | 23 premenopausal, female | Posted | Mean | Standard Deviation | counts | 90-120 days |
|
|
|
| Secondary | Clinical Symptoms of Iron Deficiency E2 | Clinical symptoms of iron deficiency at baseline (E2), numbers discribe the count of participants affected. | 23 female premenopausal 24 female post menopausal or male | Posted | Number | participants | 90-120 days |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 3 |
| 47 |
| stool | Gastrointestinal disorders | Non-systematic Assessment | occasionally loose stools |
|
| pain | General disorders | Non-systematic Assessment | pain in fingers and wrists 2 weeks after start of iron supplementation |
|
Not provided
Not provided
Not provided
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|
| Uncertainty about whether the sachets had already been taken |
|
| no adverse effects reported |
|
| Title | Measurements |
|---|---|
|
| environment |
|
| Title | Measurements |
|---|---|
|
| environment |
|
| shortness of breath |
|
| dizzyness |
|
| painful or "smooth" tongue |
|
| inexplicable food cravings |
|
| shortness of breath |
|
| dizzyness |
|
| painful or "smooth" tongue |
|
| inexplicable food cravings |
|