The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.
The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild anemia after 8 weeks of supplementation, compared to baseline values and also aims to evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used as a comparison supplement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
23
ODF iron supplement will be admistered daily for 8 weeks.
Iron supplement in capsule will be admistered daily for 8 weeks.
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, Italy, Italy
Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement
Time frame: Day 0, Week 8
Change from baseline in blood concentration of hemoglobin with test product
Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product
Time frame: Day 0, Week 4
Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of hematocrit
Evalution of the change from baseline of hematocrit after administration of test versus reference product
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of ferritin
Evalution of the change from baseline of ferritin after administration of test versus reference product
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin
Evalution of the change from baseline of transferrin after administration of test versus reference product
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin receptor
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Evalution of the change from baseline of transferrin receptor after administration of test versus reference product
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of folic acid
Evalution of the change from baseline of folic acid after administration of test versus reference product
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of serum iron
Evalution of the change from baseline of serum iron after administration of test versus reference product
Time frame: Day 0, Week4, Week 8
Change from baseline in mean corpuscolar volume (MCV)
Evalution of the change from baseline of MCV after administration of test versus reference product
Time frame: Day 0, Week4, Week 8