Sucrosomal Iron Supplementation in Blood Donors

Iron-deficiency Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

• NCT number: NCT04250298
• Study type: Interventional
• Source: Medical University of Graz
• Status: Completed
• Phase: Phase 4
• Start date: November 13, 2019
• Completion date: December 20, 2020