Pilot Study to Gain First Indications for the Impact of a Three-month's Oral Intake of an Iron Supplement With High Bioavailability on the Hemoglobin Concentration in Iron Deficient Blood Donors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Iron-deficiency
- Sponsor
- Medical University of Graz
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Hb (g/dl) at E2
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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).
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Hb (g/dl) at E2
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 90-120 days
Ferritin level after iron supplementation at examination 2 (E2, 90-120 days after iron supplementation)
Δ Ferritin (ng/ml) (E2-E1)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 90-120 days
The number of participants with problems taking sucrosomial iron is listed, categorised according to their complaints.
Recommendation
Time Frame: 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
Time Frame: day 90-120
Will sucrosomial iron will be taken again in the given case
Assumed Adverse Effects
Time Frame: 90-120 days
Assumed test product adverse effects
Quality of Life by World Health Organization Quality of Life Assessment (E2)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Restless Legs Syndrome at E1(90-120 days)
- Clinical Symptoms of Iron Deficiency E1(90-120 days)
- Clinical Symptoms of Iron Deficiency E2(90-120 days)
- Restless Legs Syndrome at E2(90-120 days)
- Frequency of Diarrhoea During Sucrosomial Iron Intake [Days](90-120 days)