Status:
COMPLETED
Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia
Lead Sponsor:
IBSA Farmaceutici Italia Srl
Collaborating Sponsors:
Informapro Srl
Conditions:
Iron Deficiencies
Eligibility:
All Genders
18-55 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05989984
Start Date
July 29 2023
End Date
August 8 2024
Last Update
January 8 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, Italy, Italy, 00128