Iron-deficiency
Conditions
Keywords
blood donors, donor rejection, sucrosomial iron, dietary supplements
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).
Interventions
DIETARY_SUPPLEMENTsucrosomial iron
oral intake of iron as sachets or capsules
Sponsors
Johannes Kepler University of Linz
Fresenius Kabi
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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. |
| 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. |
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Restless Legs Syndrome at E1 | 90-120 days | The number of participants suffering from restless legs syndrome at baseline (E1) |
| Frequency of Diarrhoea During Sucrosomial Iron Intake [Days] | 90-120 days | The number of participants who experienced diarrhoea during iron intake in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hb at E1 | day 1 | Hemoglobin at examination 1 (E1, baseline) |
| Regensburg Insomnia Scale at E1 | 28 days | 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. |
| RLS at E1 | day 1 | Restless legs syndrome at examination 1 (E1, baseline) \[yes/no\] |
| Age at E1 | day 1 | Age at examination 1 (E1, baseline) \[years\] |
| Sex | day 1 | Sex \[female/male\] |
| Body Weight | day 1 | Body weight at examination 1 (E1, baseline) \[kg\] |
| Body Heights | day 1 | Body heights at examination 1 (E1, baseline) \[cm\] |
| BMI | day 1 | Body mass index at examination 1 (E1, baseline) |
| Intake of Sucrosomial Iron I | day 1 | Participants could choose between sachets or capsules |
| Intake Number | day 90-120 | Number of sachets or capsules (one per day) taken at E2 (after 90-120 days) \[number\] |
| Intake Ratio | day 90-120 | Ratio of ingested to prescribed capsules |
| No Intake | day 90-120 | days of violation of the intake rules \[days\], where iron was not taken during the study interval |
| Relevant Pre-existing Conditions | day 1 | relevant already cured pre-existing conditions \[categories by type\] prior to study begin |
| Number of Participants Who Met Drop Out Criteria | between E1 and E2 | Drop out criteria \[categories\] occuring during the study interval (between E1 and E2) |
| SAE | 90-120 days | Serious adverse events \[categories by dype and duration\] |
| Last Menstrual Period I | 0-90 days | Time interval between the end of the last menstrual period and blood collection for examination 1 (baseline) \[days\] |
| Last Menstrual Period II | 90-120 days | Time interval between the end of the last menstrual period up to examination 2 (end of study interval after iron intake) \[days\] |
| Last Menstrual Period III | 90-120 days | Count of menstrual bleedings between blood tests (during study interval) \[number\] |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm The arm includes male and female whole blood donors who were deferred from blood donation. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Single Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 47 Participants | — |
| Age, Continuous | 42.81 years STANDARD_DEVIATION 12.88 | — |
| Ferritin | 8.71 ng/ml | — |
| Hemoglobin | 12.0 g/dl | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 47 participants | — |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 3 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Assumed Adverse Effects
Assumed test product adverse effects
Time frame: 90-120 days
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Assumed Adverse Effects | initially problems falling asleep | 1 Participants |
| Single Arm | Assumed Adverse Effects | loose stools on occasion | 1 Participants |
| Single Arm | Assumed Adverse Effects | pain in fingers and joints 2 weeks after starting the iron supplements | 1 Participants |
| Single Arm | Assumed Adverse Effects | no adverse effects reported | 44 Participants |
Primary
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
Population: 23 female premenopausal 24 female postmenopausal or male
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Fatigue Assessment Questionnaire (E2) | 9.11 Units on a scale |
p-value: 0.033t-test, 2 sided
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Ferritin (ng/ml) at E2 | 16.54 ng/ml | Standard Deviation 7.52 |
p-value: 0.548Wilcoxon (Mann-Whitney)
Primary
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
Population: 23 female, premenopausal 24 female, post menopausal or male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Hb (g/dl) at E2 | 13.07 g/dl | Standard Deviation 1.03 |
p-value: 0.031t-test, 2 sided
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Intake Evaluation | problems with iron intake | 3 Participants |
| Single Arm | Intake Evaluation | no problems with iron intake | 44 Participants |
Primary
Problems With Intake
The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.
Time frame: 90-120 days
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Problems With Intake | sachets were not easy to open | 1 participants |
| Single Arm | Problems With Intake | Uncertainty about whether the sachets had already been taken | 1 participants |
| Single Arm | Problems With Intake | initially mild sleeping problems | 1 participants |
| Single Arm | Problems With Intake | initially mild cough irritations | 1 participants |
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Single Arm | Quality of Life by World Health Organization Quality of Life Assessment (E2) | physical health | 18.4 Units on a scale |
| Single Arm | Quality of Life by World Health Organization Quality of Life Assessment (E2) | psychic health | 17.55 Units on a scale |
| Single Arm | Quality of Life by World Health Organization Quality of Life Assessment (E2) | social relationships | 17.73 Units on a scale |
| Single Arm | Quality of Life by World Health Organization Quality of Life Assessment (E2) | environment | 18.57 Units on a scale |
Comparison: sub-population 1 vs. sub-population 2: Parametric and nonparametric univariate tests: t-test for independent samples, Mann-Whitney-U test, Fisher's exact test, chi-square homogeneity test; normal distribution check by Kolmogorov-Smirnov test with Lilliefors -significance correction, type I error = 10%).~Estimate the true effect size:~Two-sided 95% confidence intervals (depending on the nature of the data sets: parametric, non-parametric or Clopper-Pearson) are calculated for all parameters.p-value: 0.919Wilcoxon (Mann-Whitney)
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Recommendation | yes | 45 Participants |
| Single Arm | Recommendation | no | 2 Participants |
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Regensburg Insomnia Scale at E2 | 7.39 Units on a scale |
p-value: 0.676t-test, 2 sided
Primary
Renewed Intake
Will sucrosomial iron will be taken again in the given case
Time frame: day 90-120
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Renewed Intake | yes | 47 Participants |
| Single Arm | Renewed Intake | no | 0 Participants |
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Δ Fatigue Assessment Questionnaire (E1-E2) | -15.53 Units on a scale |
p-value: 0.585t-test, 2 sided
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Δ Ferritin (ng/ml) (E2-E1) | 6.23 ng/ml | Standard Deviation 6.59 |
p-value: 0.401Wilcoxon (Mann-Whitney)
Primary
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
Population: 23 premenopausal women, 10 postmenopausal women and 14 men completed the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm | Δ Ferritin (ng/ml) (E2-E1) / 90 Days | 4.97 ng/ml |
p-value: 0.506Wilcoxon (Mann-Whitney)
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Δ Ferritin (ng/ml) (E2-E1) * Ratio Capsule Intake / 90 Days | 5.74 ng/ml | Standard Deviation 6.05 |
p-value: 0.506Wilcoxon (Mann-Whitney)
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Δ Hb (g/dl) (E2-E1) | 1.08 g/dl | Standard Deviation 0.9 |
p-value: 0.267t-test, 2 sided
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Δ Hb (g/dl) (E2-E1) / 90 Days | 0.99 g/dl | Standard Error 0.86 |
p-value: 0.228t-test, 2 sided
Primary
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
Population: 23 premenopausal, female 24 postmenopausal, female or men
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm | Δ Hb (g/dl) (E2-E1)* Ratio | 0.94 g/dl |
p-value: 0.267t-test, 2 sided
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Single Arm | Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) | physical health | 0.99 Units on a scale |
| Single Arm | Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) | psychic health | 0.33 Units on a scale |
| Single Arm | Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) | social relationships | 0.03 Units on a scale |
| Single Arm | Δ Quality of Life by World Health Organization Quality of Life Assessment (E1-E2) | environment | 0.33 Units on a scale |
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Δ Regensburg Insomnia Scale (E1-E2) | -1.35 Units on a scale |
p-value: 0.314Wilcoxon (Mann-Whitney)
Primary
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
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Δ Response 1 | 19 Participants |
p-value: >0.999Fisher Exact
Primary
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
Population: 23 premenopausal female 24 postmenopausal, female, or male
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Δ Response 2 | 12 Participants |
p-value: 0.318Fisher Exact
Primary
Δ Response 3
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
Population: 23 premenopausal, female 24 postmenopausal, female or male
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Δ Response 3 | 5 Participants |
p-value: 0.348Fisher Exact
Secondary
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
Population: 23 female premenopausal 24 female post menopausal or male
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | brittle nails | 17 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | increased hair loss | 13 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | load dependant headache | 5 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | shortness of breath | 13 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | dizzyness | 7 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | painful or smooth tongue | 1 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E1 | inexplicable food cravings | 0 participants |
Secondary
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
Population: 23 female premenopausal 24 female post menopausal or male
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | brittle nails | 11 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | increased hair loss | 8 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | load dependant headache | 6 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | shortness of breath | 9 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | dizzyness | 6 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | painful or smooth tongue | 0 participants |
| Single Arm | Clinical Symptoms of Iron Deficiency E2 | inexplicable food cravings | 1 participants |
Secondary
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
Population: 23 female premenopausal 24 female post menopausal or male
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Frequency of Diarrhoea During Sucrosomial Iron Intake [Days] | 0 Participants |
Secondary
Restless Legs Syndrome at E1
The number of participants suffering from restless legs syndrome at baseline (E1)
Time frame: 90-120 days
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Restless Legs Syndrome at E1 | 6 Participants |
Secondary
Restless Legs Syndrome at E2
The number of participants suffering from restless legs syndrome at baseline (E2)
Time frame: 90-120 days
Population: 23 female, premenopausal 24 female, postmenopausal or male
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Restless Legs Syndrome at E2 | 3 Participants |
Other Pre-specified
Age at E1
Age at examination 1 (E1, baseline) \[years\]
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Age at E1 | 42.81 years | Standard Deviation 12.88 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Other Pre-specified
BMI
Body mass index at examination 1 (E1, baseline)
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | BMI | 24.01 kg/m2 | Standard Deviation 3.92 |
p-value: 0.1Wilcoxon (Mann-Whitney)
Other Pre-specified
Body Heights
Body heights at examination 1 (E1, baseline) \[cm\]
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Body Heights | 169.68 cm | Standard Deviation 9.15 |
p-value: 0.111Wilcoxon (Mann-Whitney)
Other Pre-specified
Body Weight
Body weight at examination 1 (E1, baseline) \[kg\]
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Body Weight | 69.45 kg | Standard Deviation 14.82 |
p-value: 0.055Wilcoxon (Mann-Whitney)
Other Pre-specified
Hb at E1
Hemoglobin at examination 1 (E1, baseline)
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Hb at E1 | 11.99 g/dl | Standard Deviation 0.59 |
p-value: 0.031t-test, 2 sided
Other Pre-specified
Intake Number
Number of sachets or capsules (one per day) taken at E2 (after 90-120 days) \[number\]
Time frame: day 90-120
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Intake Number | 98.13 capsules/sachets | Standard Deviation 8.19 |
Other Pre-specified
Intake of Sucrosomial Iron I
Participants could choose between sachets or capsules
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Intake of Sucrosomial Iron I | sachets | 47 Participants |
| Single Arm | Intake of Sucrosomial Iron I | capsules | 0 Participants |
Other Pre-specified
Intake Ratio
Ratio of ingested to prescribed capsules
Time frame: day 90-120
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Intake Ratio | 1.03 ratio | Standard Deviation 0.04 |
p-value: 0.111Wilcoxon (Mann-Whitney)
Other Pre-specified
Last Menstrual Period I
Time interval between the end of the last menstrual period and blood collection for examination 1 (baseline) \[days\]
Time frame: 0-90 days
Population: 23 premenopausal, female
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Last Menstrual Period I | 17.74 days | Standard Deviation 10.32 |
Other Pre-specified
Last Menstrual Period II
Time interval between the end of the last menstrual period up to examination 2 (end of study interval after iron intake) \[days\]
Time frame: 90-120 days
Population: 23 female, premenopausal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Last Menstrual Period II | 16.48 days | Standard Deviation 8.99 |
Other Pre-specified
Last Menstrual Period III
Count of menstrual bleedings between blood tests (during study interval) \[number\]
Time frame: 90-120 days
Population: 23 premenopausal, female
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Last Menstrual Period III | 2.91 counts | Standard Deviation 1.02 |
Other Pre-specified
No Intake
days of violation of the intake rules \[days\], where iron was not taken during the study interval
Time frame: day 90-120
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | No Intake | 2.77 days | Standard Deviation 3.75 |
p-value: 0.213Wilcoxon (Mann-Whitney)
Other Pre-specified
Number of Participants Who Met Drop Out Criteria
Drop out criteria \[categories\] occuring during the study interval (between E1 and E2)
Time frame: between E1 and E2
Population: 25 female, premenopausal 25 female, postmenopausal or men
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants Who Met Drop Out Criteria | 3 Participants |
Other Pre-specified
Regensburg Insomnia Scale at E1
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.
Time frame: 28 days
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Regensburg Insomnia Scale at E1 | 8.96 Units on a scale |
p-value: 0.862t-test, 2 sided
Other Pre-specified
Relevant Pre-existing Conditions
relevant already cured pre-existing conditions \[categories by type\] prior to study begin
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Relevant Pre-existing Conditions | 0 Participants |
Other Pre-specified
RLS at E1
Restless legs syndrome at examination 1 (E1, baseline) \[yes/no\]
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | RLS at E1 | yes | 6 Participants |
| Single Arm | RLS at E1 | no | 41 Participants |
p-value: 0.25Fisher Exact
Other Pre-specified
SAE
Serious adverse events \[categories by dype and duration\]
Time frame: 90-120 days
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | SAE | 0 Participants |
Other Pre-specified
Sex
Sex \[female/male\]
Time frame: day 1
Population: 23 female, premenopausal 24 female, postmenopausal or men
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Sex | male | 14 Participants |
| Single Arm | Sex | female, premenopausal | 23 Participants |
| Single Arm | Sex | female,postmenopausal | 10 Participants |
p-value: 0.001Fisher Exact