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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
oral intake of iron as sachets or capsules
Medical University of Graz
Graz, Styria, Austria
Hb (g/dl) at E2
hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 90-120 days)
Time frame: 90-120 days
Δ Hb (g/dl) (E2-E1)
Change of hemoglobin between visit 1 (E1, baseline ) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Time frame: 90-120 days
Δ Hb (g/dl) (E2-E1) / 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
Time frame: 90 days
Δ Hb (g/dl) (E2-E1)* Ratio
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
Time frame: 90 days
Δ Response 1
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)
Time frame: 90 days
Δ Response 2
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)
Time frame: 90 days
Δ Response 3
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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)
Time frame: 90 days
Ferritin (ng/ml) at E2
Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)
Time frame: 90-120 days
Δ Ferritin (ng/ml) (E2-E1)
Change of Hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution
Time frame: 90-120 days
Δ Ferritin (ng/ml) (E2-E1) / 90 Days
Change of ferritin between examination 1 (E1, baseline ) to examination 2 (E2, after 90-120 days) interpolated to 90 days
Time frame: 90 days
Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 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.
Time frame: 90 days
Intake Evaluation
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
Time frame: 90-120 days
Problems With Intake
The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.
Time frame: 90-120 days
Recommendation
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.
Time frame: day 90-120
Renewed Intake
Will sucrosomial iron will be taken again in the given case
Time frame: day 90-120
Assumed Adverse Effects
Assumed test product adverse effects
Time frame: 90-120 days
Quality of Life by World Health Organization Quality of Life Assessment (E2)
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).
Time frame: 14 days
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2)
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).
Time frame: 90-120 days
Fatigue Assessment Questionnaire (E2)
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.
Time frame: 7 days
Δ Fatigue Assessment Questionnaire (E1-E2)
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.
Time frame: 7 days
Regensburg Insomnia Scale at E2
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.
Time frame: 28 days
Δ Regensburg Insomnia Scale (E1-E2)
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.
Time frame: 90-120 days
Restless Legs Syndrome at E1
The number of participants suffering from restless legs syndrome at baseline (E1)
Time frame: 90-120 days
Restless Legs Syndrome at E2
The number of participants suffering from restless legs syndrome at baseline (E2)
Time frame: 90-120 days
Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]
The number of participants who experienced diarrhoea during iron intake in days
Time frame: 90-120 days
Clinical Symptoms of Iron Deficiency E1
Clinical symptoms of iron deficiency at baseline (E1), numbers discribe the count of participants affected.
Time frame: 90-120 days
Clinical Symptoms of Iron Deficiency E2
Clinical symptoms of iron deficiency at baseline (E2), numbers discribe the count of participants affected.
Time frame: 90-120 days