Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
19 participants
INTERVENTIONAL
2016-12-31
2017-04-30
Brief Summary
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Detailed Description
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The study will take place over a period of 8 weeks.
Volunteers will be randomly assigned to two groups. Randomization will be provided by a software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or a placebo injection containing only the saline solution will be performed. Standard blood sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL blood donation will be done. Standard blood sampling and finger prick blood sampling will be performed before and after the donation.
The study will be done in "simple blind", meaning that volunteers will not know if they get iron or saline solution.
On the days of iron or saline solution injection and blood donation, blood sampling will be done up to 12 hours after the injection. After that, blood sampling will be scheduled up to 30 days after blood donation at a rate of once a day (except for the weekends).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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placebo injection group
saline solution injection as placebo
saline solution injection
Injection of a 250mL saline solution
iron injection group
iron injection
iron injection
Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
Interventions
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iron injection
Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
saline solution injection
Injection of a 250mL saline solution
Eligibility Criteria
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Inclusion Criteria
* BMI between 18 and 30
* Ferritin \< 50ug/l
* Transferrin saturation \< 20 if ferritin between 20 and 50ug/l
Exclusion Criteria
* blood donation within 6 months before the study
* liver disorder
20 Years
35 Years
MALE
Yes
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Nicolas Leuenberger
OTHER
Responsible Party
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Nicolas Leuenberger
PhD
Other Identifiers
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2016-00324
Identifier Type: -
Identifier Source: org_study_id
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