To assess the effect of whole blood donation on iron kinetics, iron absorption and iron incorporation into erythrocytes in new and frequent male whole blood donors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fysiologisch herstel na bloeddonatie in gezonde mannen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hb and red cell and reticulocyte indices (MCV, MCH, RDW, Ret Hb), serum iron
parameters (iron, ferritin, transferrin, transferrin saturation, serum
transferrin receptor (sTfR), zinc protoporphyrin (ZPP), hepcidin) and
erythropoiesis marker (EPO).
Secondary outcome
Blood volume, number of previous donations, donation frequency
Background summary
Research on iron status of new donors and frequent donors has been done before.
However, not much is known of the reaction of the human body to the loss of 500
mL of blood. How much does the iron content of the body decrease? What
parameters related to erythropoiesis, iron status and iron metabolism change,
and how do they change over time? Is the effect the same in new and frequent
donors? How long does it take for the parameters to return to predonation
levels? In this study, we will measure the effects on the body of donation of
500 mL whole blood. The results will help evaluate whether time to next
invitation should be diversified for various groups of donors.
Study objective
To assess the effect of whole blood donation on iron kinetics, iron absorption
and iron incorporation into erythrocytes in new and frequent male whole blood
donors.
Study design
Longitudinal design with 10 sample moments in 180 days.
Study burden and risks
Donors will lose 500 ml of blood with the donation and 235 ml at the sample
moments. In total, this is 735 ml. This amount does not exceed 15% of total
blood volume. The maximum proportion of blood acceptable for donation has been
put at 15% of the total blood volume.29
At every sampling moment there is a minimal risk of bleeding and infection. The
most frequent side effect of blood sampling is a haematoma in the elbow crease.
The stable isotopes of iron 57Fe and 58Fe have been repeatedly used as a
research tracer for iron bioavailability in population groups such as adults,
pregnant women, children and infants and are safe for human consumption. The
iron concentrations used in this study are within the iron concentrations
expected from dietary iron intake and are a factor 10 lower than supplemental
(pharmacological) iron dosages. No side effects for the stable iron isotopes
are ever reported.
Geert Grooteplein Zuid 34
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 34
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Male, 2 or less blood donations or 10 or more blood donations, BMI between 20 and 27, length at least 175 cm, age between 30 and 50, ALT and CRP normal at start
Exclusion criteria
vegetarian, blood type O neg, HFE mutation (homozygote C282Y or compound heterozygote C282Y/H63D genotype)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL40948.091.12 |