N/A
N=50
Sucrosom5al Iron Supplementation in Blood Donors
Iron-deficiency
Bottom Line
View on ClinicalTrials.gov: NCT04250298 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Hb (g/dl) at E2 — 13.07 g/dl — p=0.031
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sucrosomial iron (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hb (g/dl) at E2 |
13.07 | 0.031 sig |
| PRIMARY Δ Hb (g/dl) (E2-E1) |
1.08 | 0.267 |
| PRIMARY Δ Hb (g/dl) (E2-E1) / 90 Days |
0.99 | 0.228 |
| PRIMARY Δ Hb (g/dl) (E2-E1)* Ratio |
0.94 | 0.267 |
| PRIMARY Δ Response 1 |
19 | >0.999 |
| PRIMARY Δ Response 2 |
12 | 0.318 |
| PRIMARY Δ Response 3 |
5 | 0.348 |
| PRIMARY Ferritin (ng/ml) at E2 |
16.54 | 0.548 |
| PRIMARY Δ Ferritin (ng/ml) (E2-E1) |
6.23 | 0.401 |
| PRIMARY Δ Ferritin (ng/ml) (E2-E1) / 90 Days |
4.97 | 0.506 |
| PRIMARY Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 90 Days |
5.74 | 0.506 |
| PRIMARY Intake Evaluation |
3; 44 | — |
| PRIMARY Problems With Intake |
1; 1; 1; 1 | — |
| PRIMARY Recommendation |
45; 2 | — |
| PRIMARY Renewed Intake |
47; 0 | — |
| PRIMARY Assumed Adverse Effects |
1; 1; 1; 44 | — |
| PRIMARY Quality of Life by World Health Organization Quality of Life Assessment (E2) |
18.4; 17.55; 17.73; 18.57 | 0.919 |
| PRIMARY Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) |
0.99; 0.33; 0.03; 0.33 | — |
| PRIMARY Fatigue Assessment Questionnaire (E2) |
9.11 | 0.033 sig |
| PRIMARY Δ Fatigue Assessment Questionnaire (E1-E2) |
-15.53 | 0.585 |
| PRIMARY Regensburg Insomnia Scale at E2 |
7.39 | 0.676 |
| PRIMARY Δ Regensburg Insomnia Scale (E1-E2) |
-1.35 | 0.314 |
| SECONDARY Restless Legs Syndrome at E1 |
6 | — |
| SECONDARY Restless Legs Syndrome at E2 |
3 | — |
| SECONDARY Frequency of Diarrhoea During Sucrosomial Iron Intake [Days] |
— | — |
| SECONDARY Clinical Symptoms of Iron Deficiency E1 |
17; 13; 5; 13; 7; 1 | — |
| SECONDARY Clinical Symptoms of Iron Deficiency E2 |
11; 8; 6; 9; 6; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Deferral from donation because of low capillary hemoglobin (Hb) 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);
Data sourced from ClinicalTrials.gov (NCT04250298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.