NCT04250298

Sucrosom5al Iron Supplementation in Blood Donors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	sucrosomial iron	oral intake of iron as sachets or capsules

Timeline

• Start date: 2019-11-13
• Primary completion: 2020-09-28
• Completion: 2020-12-20
• First posted: 2020-01-31
• Last updated: 2025-09-16
• Results posted: 2025-09-16

Locations

1 site across 1 country: Austria