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.

Study Overview

• Status: Recruiting
• Conditions: Iron Deficiencies
• Intervention / Treatment: Dietary supplement: ODF Iron Supplement; Dietary supplement: Iron Supplement in Capsules

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Angeletti; Phone Number: +3906225411461; Email: S.Angeletti@policlinicocampus.it

Study Locations

• Italy
  • Roma, Italy, 00128
    • Recruiting
    • Fondazione Policlinico Universitario Campus Bio-Medico di Roma
    • Contact: Silvia Angeletti; Email: S.Angeletti@policlinicocampus.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ODF Iron Supplement; ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid.	Dietary supplement: ODF Iron Supplement; ODF iron supplement will be admistered daily for 8 weeks.
Active Comparator: Iron Supplement in Capsule; Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C.	Dietary supplement: Iron Supplement in Capsules; Iron supplement in capsule will be admistered daily for 8 weeks.; Other Names: Sucrosomial iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)	Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement	Day 0, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood concentration of hemoglobin with test product	Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product	Day 0, Week 4
Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)	Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule	Day 0, Week4, Week 8
Change from baseline in blood concentration of hematocrit	Evalution of the change from baseline of hematocrit after administration of test versus reference product	Day 0, Week4, Week 8
Change from baseline in blood concentration of ferritin	Evalution of the change from baseline of ferritin after administration of test versus reference product	Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin	Evalution of the change from baseline of transferrin after administration of test versus reference product	Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin receptor	Evalution of the change from baseline of transferrin receptor after administration of test versus reference product	Day 0, Week4, Week 8
Change from baseline in blood concentration of folic acid	Evalution of the change from baseline of folic acid after administration of test versus reference product	Day 0, Week4, Week 8
Change from baseline in blood concentration of serum iron	Evalution of the change from baseline of serum iron after administration of test versus reference product	Day 0, Week4, Week 8
Change from baseline in mean corpuscolar volume (MCV)	Evalution of the change from baseline of MCV after administration of test versus reference product	Day 0, Week4, Week 8

Collaborators and Investigators

• Sponsor: IBSA Farmaceutici Italia Srl
• Collaborators: Informapro Srl
• Investigators: Principal Investigator: Silvia Angeletti, Operative Research Unit of Clinical Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: IBSAFE_CLI22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No