Sucrosom5al Iron Supplementation in Blood Donors

hemoglobin level after iron supplementation at examination 2 (E2, after iron intake over 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

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

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

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)

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)

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 level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)

Change of Hemoglobin between examination 1 (E1, baseline) prior to iron substitution and examination 2 (E2, after 90-120 days) after iron substitution

Change of ferritin between examination 1 (E1, baseline ) to examination 2 (E2, after 90-120 days) interpolated to 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.

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

The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.

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.

Will sucrosomial iron will be taken again in the given case

Assumed test product adverse effects

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).

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).

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.

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.

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.

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.

The number of participants suffering from restless legs syndrome at baseline (E1)

The number of participants suffering from restless legs syndrome at baseline (E2)

The number of participants who experienced diarrhoea during iron intake in days

Clinical symptoms of iron deficiency at baseline (E1), numbers discribe the count of participants affected.

Clinical symptoms of iron deficiency at baseline (E2), numbers discribe the count of participants affected.

Hemoglobin at examination 1 (E1, baseline)

Symptoms of insomnia at examination 1 (E1, baseline) Symptoms of insomnia were determined at E 1 prior iron intake (baseline). 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 E1 is shown here.

Restless legs syndrome at examination 1 (E1, baseline) [yes/no]

Age at examination 1 (E1, baseline) [years]

Sex [female/male]

Body weight at examination 1 (E1, baseline) [kg]

Body heights at examination 1 (E1, baseline) [cm]

Body mass index at examination 1 (E1, baseline)

Participants could choose between sachets or capsules

Number of sachets or capsules (one per day) taken at E2 (after 90-120 days) [number]

Ratio of ingested to prescribed capsules

days of violation of the intake rules [days], where iron was not taken during the study interval

Drop out criteria [categories] occuring during the study interval (between E1 and E2)

relevant already cured pre-existing conditions [categories by type] prior to study begin

Serious adverse events [categories by dype and duration]

Time interval between the end of the last menstrual period and blood collection for examination 1 (baseline) [days]

Time interval between the end of the last menstrual period up to examination 2 (end of study interval after iron intake) [days]

Count of menstrual bleedings between blood tests (during study interval) [number]