Sucrosomal Iron Supplementation in Blood Donors

Phase 4

Completed

• Conditions: Iron-deficiency
• Interventions: Dietary Supplement: sucrosomal iron

• Registration Number: NCT04250298
• Lead Sponsor: Medical University of Graz

Brief Summary

The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomal 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 (sucrosomal 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 questionnaire \[FAQ\], questionnaire on psychic symptoms of insomnia \[RIS\] and Restless Legs Syndrome).

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Primary Completion: 2020-09-28
• Study Completion: 2020-12-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron deficient blood donors	sucrosomal iron	Daily intake of 30 mg of sucrosomal iron during 90-120 days (male and female whole blood donors)

Primary Outcome Measures

Name	Time	Method
Hb E1-E2/90 days g/dl	90 days	Change of hemoglobin between examination 1 (E1) prior to iron substitution and examination 2 (E2) after iron substitution/90 days
Hb at E2 g/dl	90-120 days	hemoglobin level after iron supplementation at examination 2 (E2)
Hb E1-E2/* Ratio g/dl	90 days	Change of hemoglobin ratio of prescribed/taken iron supplementation/ 90 days
Delta Ferritin E1-E2 (ng/ml)	90-120 days	Change of Hemoglobin between examination 1 (E1) prior to iron substitution and examination 2 (E2) after iron substitution
Problems with intake	90-120 days	Problems with taking sucrosomal iron \[Categories by type\]
Recommendation	day 90-120	Will use of sucrosomal iron for other blood donors be recommended \[yes/no\]
FAQ (E2)	7 days	In the Fatigue Assessment Questionnaire fatigue at examination 2 will be determined. Values range from 0-3, including 23 items. The higher the score is the worse is the outcome.
RLS (E2)	90-120 days	Restless legs syndrome at examination 2 \[yes/no\]
Delta Hb E1-E2 g/dl	90-120 days	Change of hemoglobin between visit 1 (E1) prior to iron substitution and examination 2 (E2) after iron substitution
Response 3	90 days	Change of Hb between examination 1 and examination 2 (E2)/90 days ≥2.0 g/dl \[yes/no\]
Ferritin E1-E2/Ratio capsule intake 90 days (ng/ml)	90 days	Change of ferritin ratio of prescribed/consumed iron supplementation/ 90 days
Assumed adverse effects	90-120 days	Assumed test product adverse effects \[Categories by type and severity, duration\]
Clinical symptoms of iron deficiency	90-120 days	Items of the questionnaire for basic on possible clinical symptoms of iron deficiency and for the evaluation of sucrosomal iron \[narrative, categories\]
Delta Response 1	90 days	Change of Hb between examination 1 and examination 2 /90 days ≥1.0 g/dl \[yes/no\]
Ferritin at E2 (ng/ml)	90-120 days	Ferritin level after iron supplementation at examination 2 (E2)
Renewed intake	day 90-120	Will sucrosomal iron will be taken again in the given case
Delta WHOQOL-Bref (E1-E2)	14 days	The WHO Quality of Life Assessment includes 16 items with values of 1-5. Higher scores denote a higher quality of life. In this outcome changes in quality of life are assessed by determining the differences between examination 1 and examination 2.
RIS at E2	28 days	Symptoms of insomnia (Regensburg Insomnia Scale) will be determined at examination 2. The questionnaire consists of 10 items with values of 0-4. Higher scores denote a worse outcome.
Change RIS (E1-E2)	28 days	Change of symptoms of insomnia between examination 1 and examination 2. Symptoms of insomnia (Regensburg Insomnia Scale) will be determined at examination 1 and 2. In this outcome the difference between E1 and E2 will be determined. The questionnaire consists of 10 items with values of 0-4. Higher scores denote a worse outcome.
Delta Ferritin E1-E2/90 days (ng/ml)	90 days	Change of ferritin between examination 1 (E1) to examination 2 (E2)/ 90 days
Delta Response 2	90 days	Change of Hb between examination 1 and examination 2 /90 days ≥1.5 g/dl \[yes/no\]
Intake evaluation	90-120 days	Evaluation of the intake of sucrosomal iron \[problem-free yes/no\]
WHOQOL-Bref (E2)	14 days	The WHO Quality of Life Assessment (abbreviated) includes 16 items with values of 1-5 (negatively phrased items are reversed for analysis.) Higher scores denote a higher quality of life.
Delta FAQ (E1-E2)	7 days	In the Fatigue Assessment Questionnaire fatigue will be determined at E1 and E2. Values range from 0-3. In this outcome the change of fatigue between examination 1 and examination 2 will be determined.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria