Repetitive blood donations and endurance sport performance: does iron supplementation limit the negative effects on hematological parameters?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003406-40-BE

Enrollment

Registered

2017-08-17

Start date

2017-09-08

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects moderately active undergoing repeated blood donations

Interventions

Trade Name: Losferron Pharmaceutical Form: Effervescent tablet INN or Proposed INN: FERROUS GLUCONATE CAS Number: 299-29-6 Other descrip

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - age between 18-50 years - BMI between 20-28 kg/m2 - hours sport per week between 1-6 - good health Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - hematochromatose (coefficient of transferrin saturation >45% and ferritin >300µg/l) - iron deficiency (ferritin <12µg/l) - iron supplementation - nutritional supplements intake (such as vitamins or minerals)

Design outcomes

Primary

Measure	Time frame
Main Objective: We propose to measure the impact of 3 blood donations, interspersed by 3 months, on blood parameters and on performance during a maximal incremental test and to see whether iron supplementation can limit or even reverse the negative effects of donations on blood parameters reflecting iron status. ;Secondary Objective: not applicable;Primary end point(s): VO2 max;Timepoint(s) of evaluation of this end point: one week before blood donation and 2 days after, 1 week after, 2 weeks after and 4 weeks after blood donation. This timepoints will be used at each blood donnation (3 in total), with a interval of three months	—

Measure

Time frame

Main Objective: We propose to measure the impact of 3 blood donations, interspersed by 3 months, on blood parameters and on performance during a maximal incremental test and to see whether iron supplementation can limit or even reverse the negative effects of donations on blood parameters reflecting iron status. ;Secondary Objective: not applicable;Primary end point(s): VO2 max;Timepoint(s) of evaluation of this end point: one week before blood donation and 2 days after, 1 week after, 2 weeks after and 4 weeks after blood donation. This timepoints will be used at each blood donnation (3 in total), with a interval of three months

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Secondary

Measure	Time frame
Secondary end point(s): - haematological parameters: hematocrit, hemoglobin, red blood cells, iron, transferrin, ferritin, erythropoietin, soluble transferrin receptor and hepcidin. - hemoglobin mass - sport performance during an exercise test: lactate, heart rate ;Timepoint(s) of evaluation of this end point: one week before blood donation and 2 days after, 1 week after, 2 weeks after and 4 weeks after blood donation. This timepoints will be used at each blood donnation (3 in total), with a interval of three months	—

Measure

Time frame

Secondary end point(s): - haematological parameters: hematocrit, hemoglobin, red blood cells, iron, transferrin, ferritin, erythropoietin, soluble transferrin receptor and hepcidin. - hemoglobin mass - sport performance during an exercise test: lactate, heart rate ;Timepoint(s) of evaluation of this end point: one week before blood donation and 2 days after, 1 week after, 2 weeks after and 4 weeks after blood donation. This timepoints will be used at each blood donnation (3 in total), with a interval of three months

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Countries

Belgium

Contacts

Public ContactLouise Deldicque

Université catholique de Louvain

louise.deldicque@uclouvain.be003210474443

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026