Sucrosomal Iron Supplementation in Blood Donors

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Iron-deficiency

Intervention / Treatment
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* Dietary Supplement: sucrosomal iron


Participation Criteria
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Eligibility Criteria
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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);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Iron deficient blood donors<br>Daily intake of 30 mg of sucrosomal iron during 90-120 days (male and female whole blood donors) | Dietary Supplement: sucrosomal iron<br>* oral intake of iron as sachets or capsules<br>* Other names: OLEOvital(R) EISEN FORTE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb at E2 g/dl | hemoglobin level after iron supplementation at examination 2 (E2) | 90-120 days | 
| Delta Hb E1-E2 g/dl | Change of hemoglobin between visit 1 (E1) prior to iron substitution and examination 2 (E2) after iron substitution | 90-120 days | 
| Hb E1-E2/90 days g/dl | Change of hemoglobin between examination 1 (E1) prior to iron substitution and examination 2 (E2) after iron substitution/90 days | 90 days | 
| Hb E1-E2/* Ratio g/dl | Change of hemoglobin ratio of prescribed/taken iron supplementation/ 90 days | 90 days | 
| Delta Response 1 | Change of Hb between examination 1 and examination 2 /90 days ≥1.0 g/dl [yes/no] | 90 days | 
| Delta Response 2 | Change of Hb between examination 1 and examination 2 /90 days ≥1.5 g/dl [yes/no] | 90 days | 
| Response 3 | Change of Hb between examination 1 and examination 2 (E2)/90 days ≥2.0 g/dl [yes/no] | 90 days | 
| Ferritin at E2 (ng/ml) | Ferritin level after iron supplementation at examination 2 (E2) | 90-120 days | 
| Delta Ferritin E1-E2 (ng/ml) | Change of Hemoglobin between examination 1 (E1) prior to iron substitution and examination 2 (E2) after iron substitution | 90-120 days | 
| Delta Ferritin E1-E2/90 days (ng/ml) | Change of ferritin between examination 1 (E1) to examination 2 (E2)/ 90 days | 90 days | 
| Ferritin E1-E2/Ratio capsule intake 90 days (ng/ml) | Change of ferritin ratio of prescribed/consumed iron supplementation/ 90 days | 90 days | 
| Intake evaluation | Evaluation of the intake of sucrosomal iron [problem-free yes/no] | 90-120 days | 
| Problems with intake | Problems with taking sucrosomal iron [Categories by type] | 90-120 days | 
| Recommendation | Will use of sucrosomal iron for other blood donors be recommended [yes/no] | day 90-120 | 
| Renewed intake | Will sucrosomal iron will be taken again in the given case | day 90-120 | 
| Assumed adverse effects | Assumed test product adverse effects [Categories by type and severity, duration] | 90-120 days | 
| Clinical symptoms of iron deficiency | Items of the questionnaire for basic on possible clinical symptoms of iron deficiency and for the evaluation of sucrosomal iron [narrative, categories] | 90-120 days | 
| WHOQOL-Bref (E2) | The WHO Quality of Life Assessment (abbreviated) includes 16 items with values of 1-5 (negatively phrased items are reversed for analysis.) Higher scores denote a higher quality of life. | 14 days | 
| Delta WHOQOL-Bref (E1-E2) | The WHO Quality of Life Assessment includes 16 items with values of 1-5. Higher scores denote a higher quality of life. In this outcome changes in quality of life are assessed by determining the differences between examination 1 and examination 2. | 14 days | 
| FAQ (E2) | In the Fatigue Assessment Questionnaire fatigue at examination 2 will be determined. Values range from 0-3, including 23 items. The higher the score is the worse is the outcome. | 7 days | 
| Delta FAQ (E1-E2) | In the Fatigue Assessment Questionnaire fatigue will be determined at E1 and E2. Values range from 0-3. In this outcome the change of fatigue between examination 1 and examination 2 will be determined. | 7 days | 
| RIS at E2 | Symptoms of insomnia (Regensburg Insomnia Scale) will be determined at examination 2. The questionnaire consists of 10 items with values of 0-4. Higher scores denote a worse outcome. | 28 days | 
| Change RIS (E1-E2) | Change of symptoms of insomnia between examination 1 and examination 2. Symptoms of insomnia (Regensburg Insomnia Scale) will be determined at examination 1 and 2. In this outcome the difference between E1 and E2 will be determined. The questionnaire consists of 10 items with values of 0-4. Higher scores denote a worse outcome. | 28 days | 
| RLS (E2) | Restless legs syndrome at examination 2 [yes/no] | 90-120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood donors, donor rejection, sucrosomal iron, dietary supplements