Repetitive blood donations and endurance sport performance: does iron supplementation limit the negative effects on hematological parameters?
Phase 1
- Conditions
- healthy subjects moderately active undergoing repeated blood donationsTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2017-003406-40-BE
- Lead Sponsor
- niversité catholique de Louvain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 44
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
- 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - haematological parameters: hematocrit, hemoglobin, red blood cells, iron, transferrin, ferritin, erythropoietin, soluble transferrin receptor and hepcidin.<br> - hemoglobin mass<br> - sport performance during an exercise test: lactate, heart rate<br> ;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