Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia
- Conditions
- Iron Deficiencies
- Registration Number
- NCT05989984
- Lead Sponsor
- IBSA Farmaceutici Italia Srl
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 transferrin receptor Day 0, Week4, Week 8 Evalution of the change from baseline of transferrin receptor after administration of test versus reference 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 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
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
🇮🇹Roma, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma🇮🇹Roma, Italy