Clinical trial NCT04250298: Sucrosomal Iron Supplementation in Blood Donors
Official title: Pilot Study to Gain First Indications for the Impact of a Three-month's Oral Intake of an Iron Supplement With High Bioavailability on the Hemoglobin Concentration in Iron Deficient Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron-deficiency
Keywords: blood donors
donor rejection
sucrosomal iron
dietary supplements
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi Austria GmbH, Graz
name: Johannes Kepler University of Linz
First posted: 2020-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: TREATMENT

Brief summary: 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.

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 (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).

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);

Primary outcomes:
measure: Hb at E2 g/dl
timeFrame: 90-120 days
measure: Delta Hb E1-E2 g/dl
timeFrame: 90-120 days
measure: Hb E1-E2/90 days g/dl
timeFrame: 90 days
measure: Hb E1-E2/* Ratio g/dl
timeFrame: 90 days
measure: Delta Response 1
timeFrame: 90 days
measure: Delta Response 2
timeFrame: 90 days
measure: Response 3
timeFrame: 90 days
measure: Ferritin at E2 (ng/ml)
timeFrame: 90-120 days
measure: Delta Ferritin E1-E2 (ng/ml)
timeFrame: 90-120 days
measure: Delta Ferritin E1-E2/90 days (ng/ml)
timeFrame: 90 days
measure: Ferritin E1-E2/Ratio capsule intake 90 days (ng/ml)
timeFrame: 90 days
measure: Intake evaluation
timeFrame: 90-120 days
measure: Problems with intake
timeFrame: 90-120 days
measure: Recommendation
timeFrame: day 90-120
measure: Renewed intake
timeFrame: day 90-120
measure: Assumed adverse effects
timeFrame: 90-120 days
measure: Clinical symptoms of iron deficiency
timeFrame: 90-120 days
measure: WHOQOL-Bref (E2)
timeFrame: 14 days
measure: Delta WHOQOL-Bref (E1-E2)
timeFrame: 14 days
measure: FAQ (E2)
timeFrame: 7 days
measure: Delta FAQ (E1-E2)
timeFrame: 7 days
measure: RIS at E2
timeFrame: 28 days
measure: Change RIS (E1-E2)
timeFrame: 28 days
measure: RLS (E2)
timeFrame: 90-120 days
Secondary outcomes:
Other outcomes:
measure: Hb at E1
timeFrame: day 1
measure: RIS at E1
timeFrame: day 1
measure: RLS at E1
timeFrame: day 1
measure: Age at E1
timeFrame: day 1
measure: Sex
timeFrame: day 1
measure: Body weight
timeFrame: day 1
measure: Body heights
timeFrame: day 1
measure: BMI
timeFrame: day 1
measure: Intake of sucrosomal iron I
timeFrame: day 1
measure: Intake number
timeFrame: day 90-120
measure: Intake ratio
timeFrame: day 90-120
measure: No intake
timeFrame: day 90-120
measure: Diarrhoea
timeFrame: 90-120 days
measure: Drop out criteria
timeFrame: day 1
measure: Relevant premedication
timeFrame: day 1
measure: Relevant medication
timeFrame: day 1
measure: Relevant pre-existing conditions
timeFrame: day 1
measure: Accompanying diseases
timeFrame: day 1
measure: SAE
timeFrame: 90-120 days
measure: Time intervals
timeFrame: 90-120 days
measure: Last menstrual period I
timeFrame: 0-90 days
measure: Last menstrual period II
timeFrame: 90-120 days
measure: Last menstrual period III
timeFrame: 90-120 days
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
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