Sucrosom5al Iron Supplementation in Blood Donors

Not Applicable

Completed

Conditions: Iron-deficiency

Registration Number: NCT04250298

Lead Sponsor: Medical University of Graz

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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);

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hb (g/dl) at E2	90-120 days	hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 90-120 days)
Δ Hb (g/dl) (E2-E1)	90-120 days	Change of hemoglobin between visit 1 (E1, baseline ) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Δ Hb (g/dl) (E2-E1) / 90 Days	90 days	Change of hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution interpolated to 90 days
Δ Hb (g/dl) (E2-E1)* Ratio	90 days	Change of hemoglobin ratio of prescribed/taken iron supplementation/ 90 days (E1, baseline; E2, after 90-120 days) For practical reasons, the period between the first and the second examination and thus the duration of iron intake varied from 90 to 120 days. Therefore, as a result, all outcomes were standardized ot 90 days by interpolation
Δ Response 1	90 days	Change of Hb between examination 1 and examination 2 /90 days ≥1.0 g/dl \[yes/no\] --\> The number of subjects in whom the Hb value improved by at least 1 g/dl between E1 (baseline) and E2 (after 90-120 days, following iron supplementation intake)
Δ Response 2	90 days	Change of Hb between examination 1 and examination 2 /90 days ≥1.5 g/dl \[yes/no\] --\> The number of subjects in whom the Hb value improved by at least 1.5 g/dl between E1 (baseline) and E2 (after 90-120 days of iron supplementation intake)
Δ Response 3	90 days	Change of Hb between examination 1 and examination 2 (E2)/90 days ≥2.0 g/dl \[yes/no\] --\> The number of subjects in whom the Hb value improved by at least 2 g/dl between E1 (baseline) and E2 (after 90-120 days of iron supplementation intake)
Ferritin (ng/ml) at E2	90-120 days	Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)
Δ Ferritin (ng/ml) (E2-E1)	90-120 days	Change of Hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Δ Ferritin (ng/ml) (E2-E1) / 90 Days	90 days	Change of ferritin between examination 1 (E1, baseline ) to examination 2 (E2, after 90-120 days) interpolated to 90 days
Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 90 Days	90 days	Difference of ferritin values in ng/ml by comparing levels at baseline and 90-120 days after iron supplementation (interpolated to 90 days) A positive value for mean is considered an improvement.
Intake Evaluation	90-120 days	Evaluation of the intake of sucrosomial iron \[problem-free yes/no\] --\> The number of participants who reported problems with the intake of the iron sachets
Problems With Intake	90-120 days	The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.
Recommendation	day 90-120	Will use of sucrosomial iron for other blood donors be recommended \[yes/no\] --\> The number refers to the number of participants who would recommend taking the product to others.
Renewed Intake	day 90-120	Will sucrosomial iron will be taken again in the given case
Assumed Adverse Effects	90-120 days	Assumed test product adverse effects
Quality of Life by World Health Organization Quality of Life Assessment (E2)	14 days	Assessment of Scores at E2 after 90-120 days of iron intake. The WHOQOL-Bref includes 26 items with values of 1-5 addressing 4 domains (neg. phrased items are reversed for analysis.) Higher scores denote a higher quality of life, but there are no cut-off points above or below which quality of life could be evaluated as poor or good. Physical health: 7 items (4-20) Psychic health: 6 items (4-20) Social relationships: 3 items (4-20) Environment: 8 items (4-20) Score calculation: Domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life (without adjusting to WHOQOL-100). Conversion to the final score (summarizing all 4 domains) was not performed (only the differences between E1 and E2 were of interest).
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2)	90-120 days	Differences in the WHOQOL BREF categories between E1 (baseline) and E2 (after 90-120 days of iron intake). The WHOQOL-Bref includes 26 items with values of 1-5 addressing 4 domains (neg. phrased items are reversed for analysis.) Higher scores denote a higher quality of life, but there are no cut-off points above or below which quality of life could be evaluated as poor or good. Physical health: 7 items (4-20) Psychic health: 6 items (4-20) Social relationships: 3 items (4-20) Environment: 8 items (4-20) Score calculation: Domain and facet scores are scaled in a positive direction where higher scores denote higer qualitiy of life (without adjusting to WHOQOL-100). Conversion to the final score (summarizing all 4 domains) was not performed (only the differences between E1 and E2 were of interest).
Fatigue Assessment Questionnaire (E2)	7 days	Assessment of the score at E2 (after 90-120 days of iron intake). The Fatigue Assessment Questionnaire (FAQ) is a 20-item self-report scale evaluating symptoms of chronic fatigue. Values range from 0-3. The total score ranges from 0 to 60, with a higher score indicating more severe fatigue. The answers to the questions had to refer to the past week in accordance with the FAQ guidelines, so 7 days was given as the outcome measure time frame. The mean with confidence interval (95%) for fatigue at E2 is shown here.
Regensburg Insomnia Scale at E2	28 days	Symptoms of insomnia were determined at examination 2 after 90-120 days of iron intake. The questionnaire consists of 10 items with values of 0-4. Total scores range from 0 to 40 points with higher scores indicative of more psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are an indication of symptoms associated with insomnia. The questions in the questionnaire relate to the last 4 weeks, so the time of the results measurement was set at 28 days. The mean with confidence interval (95%) for insomnia at E2 is shown here.
Δ Fatigue Assessment Questionnaire (E1-E2)	7 days	In the Fatigue Assessment Questionnaire (FAQ) fatigue was determined at E1 and E2. The Fatigue Assessment Questionnaire (FAQ) is a 20-item self-report scale evaluating symptoms of chronic fatigue. Values range from 0-3. The total score ranges from 0 to 60, with a higher score indicating more severe fatigue. In this outcome the change of fatigue between examination 1 (E1, baseline) and examination 2 (after 90-120 days of iron intake) was determined. The answers to the questions had to refer to the past week in accordance with the FAQ guidelines, so 7 days was given as the outcome measure time frame. The number of subjects with fatigue before and after the intervention was analysed. A reduction in the number is considered an improvement. The mean (difference) with confidence interval (95%) for fatigue (E1-E2) is shown here.
Δ Regensburg Insomnia Scale (E1-E2)	90-120 days	Change of symptoms of insomnia between examination 1 and examination 2. Symptoms of insomnia (Regensburg Insomnia Scale) were determined at examination 1 and 2. In this outcome the difference between E1 (baseline) and E2 (after 90-120 days of iron intake) was determined. The questionnaire consists of 10 items with values of 0-4. Total scores range from 0 to 40 points with higher scores indicative of more psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are an indication of symptoms associated with insomnia. A reduction in the score between E1 and E2 is considered an improvement in sleep. The mean (difference) with confidence interval (95%) for insomnia (E1-E2) is shown here.

Secondary Outcome Measures

Name	Time	Method
Restless Legs Syndrome at E1	90-120 days	The number of participants suffering from restless legs syndrome at baseline (E1)
Clinical Symptoms of Iron Deficiency E1	90-120 days	Clinical symptoms of iron deficiency at baseline (E1), numbers discribe the count of participants affected.
Clinical Symptoms of Iron Deficiency E2	90-120 days	Clinical symptoms of iron deficiency at baseline (E2), numbers discribe the count of participants affected.
Restless Legs Syndrome at E2	90-120 days	The number of participants suffering from restless legs syndrome at baseline (E2)
Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]	90-120 days	The number of participants who experienced diarrhoea during iron intake in days