Sucrosom5al Iron Supplementation in Blood Donors

NCT ID: NCT04250298

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2020-12-20

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron deficient blood donors

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

Group Type: OTHER

sucrosomial iron

Intervention Type: DIETARY_SUPPLEMENT

oral intake of iron as sachets or capsules

Interventions

sucrosomial iron

oral intake of iron as sachets or capsules

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

OLEOvital(R) EISEN FORTE

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johannes Kepler University of Linz

OTHER

Sponsor Role: collaborator

Fresenius Kabi

INDUSTRY

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

31-435 ex 18/19

Identifier Type: -

Identifier Source: org_study_id