This pilot study will enable us to assess critical sample points in time to be able to draw a reliable curve of the concentration of various parameters that play a role in iron kinetics. This is essential for the planning of future research into theā¦
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
Blood will be drawn 11 times in 8 weeks. DNA will be isolated and stored, and
iron parameters measured. Furthermore, the participants will be asked to
complete a shortened food frequency questionnaire specifically aimed at
measuring iron intake, developed by the university of Wageningen.
The iron parameters included in this study are:
Hemoglobin (Hb)
Mean Corpuscular Volume (MCV)
soluble transferrin receptor (sTR)
Hepcidin
Iron
Transferrin
Reticulocytes and Reticulocyte Hb
Ferritin
C-Reactive Protein (CRP)
Zinc ProtoPorfyrin (ZPP)
Samples will be taken pre-donation, on the day of donation at 1, 2, 4 and 8
hours after donation and on days 2, 4, 8, 15, 29, 57 after donation. Not all
parameters will be measured at all times. The timing of specific measurements
can be found in the protocol.
Secondary outcome
None
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. The knowledge might also be
used in trauma patients.
However, before the study can be carried out in various groups of donors, it
needs to be clear which parameters must be measured at what time after donation
to characterize iron kinetics. There are no data in the literature. We will
therefore carry out a pilot study among three donors, in which at multiple
moments after donation blood will be drawn to analyse the parameters that
characterize the iron kinetics. (absorption, distribution, metabolism and
excretion, ADME).
Study objective
This pilot study will enable us to assess critical sample points in time to be
able to draw a reliable curve of the concentration of various parameters that
play a role in iron kinetics. This is essential for the planning of future
research into the adaptation to blood donation in groups of donors.
Study design
This pilot study will be a longitudinal study with repeated measurements.
Study burden and risks
The burden to the participants of this study is moderately large. After
donation, they need to spend 8 hours on the Centre for Clinical Research where
they will be given a catheter to facilitate blood sampling. This brings minimal
risks for bleeding, infection and clots. In the days and weeks following
donation another 6 sampling moments will follow. For these, the participants
need to present at the blood bank. Again, a small risk of bleeding and
infection is present.
The most frequent side effect of blood sampling is a hematoma in the
elbowcrease.
The participants will lose more blood than usually at donation. However, as we
will select tall healthy men, the total amount of blood taken does not exceed
13% of total blood volume. This is similar to the proportion of bloodvolume
taken from smaller donors in regular donations.
Postbus 1013
6501 BA Nijmegen
NL
Postbus 1013
6501 BA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Male, Donor since max 2 years, BMI between 20 and 27, length at least 175 cm, age between 30 and 60, ferritin at start between 120 and 250 microgram per litre, ALAT and CRP normal at start
Exclusion criteria
vegetarian, blood type O neg
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 | NL31690.091.10 |