Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia

Monocentric, Prospective, Randomized Study 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 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.

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