Iron Deficiencies
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTODF Iron Supplement
ODF iron supplement will be admistered daily for 8 weeks.
DIETARY_SUPPLEMENTIron Supplement in Capsules
Iron supplement in capsule will be admistered daily for 8 weeks.
Sponsors
Informapro Srl
IBSA Farmaceutici Italia Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
No masking procedure will be applied
Intervention model description
Monocentric, prospective, randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent signed prior to inclusion in the study * 18-55 years * Ability to understand the nature and the purpose of the study, including possible risks and side effects * Capability to collaborate with the investigator and meet the requirements of the entire study * Subjects with mild anemia (with WHO hemoglobin values between 11-11.9 g/dl for women and between 11-12.9 g/dl for men)
Exclusion criteria
* Clinically significant abnormalities in the ECG evaluation * Clinically significant abnormal laboratory values indicative of disease * Known allergy or presumed hypersensitivity to the food supplement investigated (iron) and / or to the excipients of the two formulations * History of anaphylaxis from drugs, dietary supplements or allergic reactions in general, which the investigator believed could influence the outcome of the study * Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study * Taking herbal remedies and dietary supplements (including iron supplements, supplements with vitamin C, supplements with folic acid, supplements with vitamin B12, multivitamins) in the 2 weeks prior to the start of the study * Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics * Alcohol abuse * Any clinical condition that in the investigator's judgment is deemed incompatible with study participation * Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product) | Day 0, Week 8 | Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product) | Day 0, Week4, Week 8 | Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule |
| Change from baseline in blood concentration of hematocrit | Day 0, Week4, Week 8 | Evalution of the change from baseline of hematocrit after administration of test versus reference product |
| Change from baseline in blood concentration of ferritin | Day 0, Week4, Week 8 | Evalution of the change from baseline of ferritin after administration of test versus reference product |
| Change from baseline in blood concentration of transferrin | Day 0, Week4, Week 8 | Evalution of the change from baseline of transferrin after administration of test versus reference product |
| Change from baseline in blood concentration of hemoglobin with test product | Day 0, Week 4 | Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product |
| Change from baseline in blood concentration of folic acid | Day 0, Week4, Week 8 | Evalution of the change from baseline of folic acid after administration of test versus reference product |
| Change from baseline in blood concentration of serum iron | Day 0, Week4, Week 8 | Evalution of the change from baseline of serum iron after administration of test versus reference product |
| Change from baseline in mean corpuscolar volume (MCV) | Day 0, Week4, Week 8 | Evalution of the change from baseline of MCV after administration of test versus reference product |
| Change from baseline in blood concentration of transferrin receptor | Day 0, Week4, Week 8 | Evalution of the change from baseline of transferrin receptor after administration of test versus reference product |
Countries
Italy
Outcome results
None listed