Clinical trial NCT05989984: Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiencies
Lead sponsor: IBSA Farmaceutici Italia Srl
Sponsor class: INDUSTRY
Collaborators: name: Informapro Srl
First posted: 2023-08-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, prospective, randomized study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
timeFrame: Day 0, Week 8
Secondary outcomes:
measure: Change from baseline in blood concentration of hemoglobin with test product
timeFrame: Day 0, Week 4
measure: Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in blood concentration of hematocrit
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in blood concentration of ferritin
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in blood concentration of transferrin
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in blood concentration of transferrin receptor
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in blood concentration of folic acid
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in blood concentration of serum iron
timeFrame: Day 0, Week4, Week 8
measure: Change from baseline in mean corpuscolar volume (MCV)
timeFrame: Day 0, Week4, Week 8
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Study officials:
affiliation: Operative Research Unit of Clinical Laboratory
name: Silvia Angeletti
role: PRINCIPAL_INVESTIGATOR
References: