The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Unnamed facility
Copenhagen, Denmark
Physical Fatigue
Time frame: From exposure to 12 weeks post-exposure
Change in Hb concentration
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-ferritin
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Fatigue symptoms
Time frame: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Postpartum depression
Time frame: From week 1 to 3, 8 and 12
Breastfeeding
Time frame: From exposure to 12 weeks post-exposure
Number of adverse drug reactions (ADRs)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-iron
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-transferrin
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in transferrin saturation (TSAT)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in reticulocyte count
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
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Change mean reticulocyte haemoglobin content (CHr)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12