Sucrosomal Iron Supplementation in Blood Donors

Medical University of Graz

Status and phase

Completed

Phase 4

Conditions

Iron-deficiency

Treatments

Dietary Supplement: sucrosomal iron

Study type

Interventional

Funder types

Other

Identifiers

NCT04250298

31-435 ex 18/19

Details and patient eligibility

About

The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomal iron preparation in whole blood donors with iron deficiency for three months.

Full 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 (sucrosomal 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 questionnaire [FAQ], questionnaire on psychic symptoms of insomnia [RIS] and Restless Legs Syndrome).

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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);