Trial Outcomes & Findings for Sucrosom5al Iron Supplementation in Blood Donors (NCT NCT04250298)

NCT ID: NCT04250298

Last Updated: 2025-09-16

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 90-120 days
• Results posted on: 2025-09-16

Participant Flow

Participant milestones

Measure	Single Arm The arm includes male and female whole blood donors who were deferred from blood donation.
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Age, Categorical <=18 years	0 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=47 Participants
Age, Categorical >=65 years	0 Participants n=47 Participants
Age, Continuous	42.81 years STANDARD_DEVIATION 12.88 • n=47 Participants
Sex: Female, Male Female	33 Participants n=47 Participants
Sex: Female, Male Male	14 Participants n=47 Participants
Region of Enrollment Austria	47 participants n=47 Participants
Hemoglobin	12.0 g/dl n=47 Participants
Ferritin	8.71 ng/ml n=47 Participants

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, post menopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Hb (g/dl) at E2	13.07 g/dl Standard Deviation 1.03

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Hb (g/dl) (E2-E1)	1.08 g/dl Standard Deviation 0.9

PRIMARY outcome

Timeframe: 90 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Hb (g/dl) (E2-E1) / 90 Days	0.99 g/dl Standard Error 0.86

PRIMARY outcome

Timeframe: 90 days

Population: 23 premenopausal, female 24 postmenopausal, female or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Hb (g/dl) (E2-E1)* Ratio	0.94 g/dl Interval 0.3 to 1.63

PRIMARY outcome

Timeframe: 90 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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)

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Response 1	19 Participants

PRIMARY outcome

Timeframe: 90 days

Population: 23 premenopausal female 24 postmenopausal, female, or male

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)

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Response 2	12 Participants

PRIMARY outcome

Timeframe: 90 days

Population: 23 premenopausal, female 24 postmenopausal, female or male

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)

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Response 3	5 Participants

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Ferritin (ng/ml) at E2	16.54 ng/ml Standard Deviation 7.52

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Ferritin (ng/ml) (E2-E1)	6.23 ng/ml Standard Deviation 6.59

PRIMARY outcome

Timeframe: 90 days

Population: 23 premenopausal women, 10 postmenopausal women and 14 men completed the study

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Ferritin (ng/ml) (E2-E1) / 90 Days	4.97 ng/ml Interval 1.23 to 8.83

PRIMARY outcome

Timeframe: 90 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 90 Days	5.74 ng/ml Standard Deviation 6.05

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Intake Evaluation problems with iron intake	3 Participants
Intake Evaluation no problems with iron intake	44 Participants

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Problems With Intake initially mild sleeping problems	1 participants
Problems With Intake initially mild cough irritations	1 participants
Problems With Intake sachets were not easy to open	1 participants
Problems With Intake Uncertainty about whether the sachets had already been taken	1 participants

PRIMARY outcome

Timeframe: day 90-120

Population: 23 female, premenopausal 24 female, postmenopausal or male

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Recommendation yes	45 Participants
Recommendation no	2 Participants

PRIMARY outcome

Timeframe: day 90-120

Population: 23 female, premenopausal 24 female, postmenopausal or male

Will sucrosomial iron will be taken again in the given case

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Renewed Intake yes	47 Participants
Renewed Intake no	0 Participants

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

Assumed test product adverse effects

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Assumed Adverse Effects initially problems falling asleep	1 Participants
Assumed Adverse Effects loose stools on occasion	1 Participants
Assumed Adverse Effects pain in fingers and joints 2 weeks after starting the iron supplements	1 Participants
Assumed Adverse Effects no adverse effects reported	44 Participants

PRIMARY outcome

Timeframe: 14 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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).

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Quality of Life by World Health Organization Quality of Life Assessment (E2) physical health	18.4 Units on a scale Interval 18.04 to 18.76
Quality of Life by World Health Organization Quality of Life Assessment (E2) psychic health	17.55 Units on a scale Interval 17.17 to 17.94
Quality of Life by World Health Organization Quality of Life Assessment (E2) social relationships	17.73 Units on a scale Interval 17.07 to 18.39
Quality of Life by World Health Organization Quality of Life Assessment (E2) environment	18.57 Units on a scale Interval 18.22 to 18.93

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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).

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) physical health	0.99 Units on a scale Interval 0.53 to 1.44
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) psychic health	0.33 Units on a scale Interval 0.03 to 0.64
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) social relationships	0.03 Units on a scale Interval -0.58 to 0.64
Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) environment	0.33 Units on a scale Interval 0.11 to 0.55

PRIMARY outcome

Timeframe: 7 days

Population: 23 female premenopausal 24 female postmenopausal or male

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Fatigue Assessment Questionnaire (E2)	9.11 Units on a scale Interval 6.47 to 11.76

PRIMARY outcome

Timeframe: 7 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Fatigue Assessment Questionnaire (E1-E2)	-15.53 Units on a scale Interval -20.08 to -10.98

PRIMARY outcome

Timeframe: 28 days

Population: 23 female, premenopausal 24 female, postmenopausal or men

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Regensburg Insomnia Scale at E2	7.39 Units on a scale Interval 6.16 to 8.62

PRIMARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or men

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Δ Regensburg Insomnia Scale (E1-E2)	-1.35 Units on a scale Interval -2.31 to -0.39

SECONDARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Restless Legs Syndrome at E1	6 Participants

SECONDARY outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Restless Legs Syndrome at E2	3 Participants

SECONDARY outcome

Timeframe: 90-120 days

Population: 23 female premenopausal 24 female post menopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Frequency of Diarrhoea During Sucrosomial Iron Intake [Days]	0 Participants

SECONDARY outcome

Timeframe: 90-120 days

Population: 23 female premenopausal 24 female post menopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Clinical Symptoms of Iron Deficiency E1 brittle nails	17 participants
Clinical Symptoms of Iron Deficiency E1 increased hair loss	13 participants
Clinical Symptoms of Iron Deficiency E1 load dependant headache	5 participants
Clinical Symptoms of Iron Deficiency E1 shortness of breath	13 participants
Clinical Symptoms of Iron Deficiency E1 dizzyness	7 participants
Clinical Symptoms of Iron Deficiency E1 painful or "smooth" tongue	1 participants
Clinical Symptoms of Iron Deficiency E1 inexplicable food cravings	0 participants

SECONDARY outcome

Timeframe: 90-120 days

Population: 23 female premenopausal 24 female post menopausal or male

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Clinical Symptoms of Iron Deficiency E2 brittle nails	11 participants
Clinical Symptoms of Iron Deficiency E2 increased hair loss	8 participants
Clinical Symptoms of Iron Deficiency E2 load dependant headache	6 participants
Clinical Symptoms of Iron Deficiency E2 shortness of breath	9 participants
Clinical Symptoms of Iron Deficiency E2 dizzyness	6 participants
Clinical Symptoms of Iron Deficiency E2 painful or "smooth" tongue	0 participants
Clinical Symptoms of Iron Deficiency E2 inexplicable food cravings	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

Hemoglobin at examination 1 (E1, baseline)

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Hb at E1	11.99 g/dl Standard Deviation 0.59

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: 23 female, premenopausal 24 female, postmenopausal or men

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.

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Regensburg Insomnia Scale at E1	8.96 Units on a scale Interval 7.49 to 10.42

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
RLS at E1 yes	6 Participants
RLS at E1 no	41 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Age at E1	42.81 years Standard Deviation 12.88

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

Sex [female/male]

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Sex male	14 Participants
Sex female, premenopausal	23 Participants
Sex female,postmenopausal	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Body Weight	69.45 kg Standard Deviation 14.82

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Body Heights	169.68 cm Standard Deviation 9.15

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

Body mass index at examination 1 (E1, baseline)

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
BMI	24.01 kg/m2 Standard Deviation 3.92

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

Participants could choose between sachets or capsules

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Intake of Sucrosomial Iron I sachets	47 Participants
Intake of Sucrosomial Iron I capsules	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: day 90-120

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Intake Number	98.13 capsules/sachets Standard Deviation 8.19

OTHER_PRE_SPECIFIED outcome

Timeframe: day 90-120

Population: 23 female, premenopausal 24 female, postmenopausal or men

Ratio of ingested to prescribed capsules

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Intake Ratio	1.03 ratio Standard Deviation 0.04

OTHER_PRE_SPECIFIED outcome

Timeframe: day 90-120

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
No Intake	2.77 days Standard Deviation 3.75

OTHER_PRE_SPECIFIED outcome

Timeframe: between E1 and E2

Population: 25 female, premenopausal 25 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=50 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Number of Participants Who Met Drop Out Criteria	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1

Population: 23 female, premenopausal 24 female, postmenopausal or men

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

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Relevant Pre-existing Conditions	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal 24 female, postmenopausal or men

Serious adverse events [categories by dype and duration]

Outcome measures

Measure	Single Arm n=47 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
SAE	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-90 days

Population: 23 premenopausal, female

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

Outcome measures

Measure	Single Arm n=23 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Last Menstrual Period I	17.74 days Standard Deviation 10.32

OTHER_PRE_SPECIFIED outcome

Timeframe: 90-120 days

Population: 23 female, premenopausal

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

Outcome measures

Measure	Single Arm n=23 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Last Menstrual Period II	16.48 days Standard Deviation 8.99

OTHER_PRE_SPECIFIED outcome

Timeframe: 90-120 days

Population: 23 premenopausal, female

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

Outcome measures

Measure	Single Arm n=23 Participants The arm includes male and female whole blood donors who were deferred from blood donation.
Last Menstrual Period III	2.91 counts Standard Deviation 1.02

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm n=47 participants at risk The arm includes male and female whole blood donors who were deferred from blood donation.
General disorders Sleep	2.1% 1/47 • Number of events 1 • Adverse events were queried at the second visit, i.e. 90-120 days after the first visit. We used a food supplement in the dosage recommended by the manufacturer, already known to be well tolerated in (apart from iron deficiency) healthy blood donors. Therefore neither serious adverse events, nor a risk for all-cause mortality was expected.
Gastrointestinal disorders stool	2.1% 1/47 • Number of events 1 • Adverse events were queried at the second visit, i.e. 90-120 days after the first visit. We used a food supplement in the dosage recommended by the manufacturer, already known to be well tolerated in (apart from iron deficiency) healthy blood donors. Therefore neither serious adverse events, nor a risk for all-cause mortality was expected.
General disorders pain	2.1% 1/47 • Number of events 1 • Adverse events were queried at the second visit, i.e. 90-120 days after the first visit. We used a food supplement in the dosage recommended by the manufacturer, already known to be well tolerated in (apart from iron deficiency) healthy blood donors. Therefore neither serious adverse events, nor a risk for all-cause mortality was expected.

Additional Information

Dr. Camilla Drexler-Helmberg

Medical University Graz

Phone: 0043316385

Email: camilla.drexler@uniklinikum.kages.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place