Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules

Comparative Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of a New Iron Supplement (With Orodispersible Formulation) vs an Iron Supplement in Capsules, After Administration of a Single Dose in Healthy Volunteers

Open, monocentric, comparative, cross-over study to evaluate the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Dietary supplement: IBSA Iron ODF; Dietary supplement: SiderAL® FORTE

Detailed Description

Open, monocentric, comparative cross-over study to compare the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years.

IBSA Iron is a food supplement based on ferric pyrophosphate and folic acid in orodispersible film.

SiderAL® FORTE is a preparation based on ferric pyrophosphate and Vit.C in capsules.

Each subject will be observed for two consecutive days (phase I, day -1 and day 0) and after a 7-day washout (phase II) for an additional two consecutive days (day -1 and day 0). Half of the enrolled subjects will take A in phase I and B in phase II; the remaining half of the enrolled subjects will take B in phase I and A in phase II.

In the two days (day -1 and day 0) of both phases, peripheral blood samples will be taken and the defined parameters, indicative of blood iron levels, will be measured.

The primary endpoint is the AUC0-t, Tmax and Cmax of serum iron. The secondary endpoints are the standard parameters indicative of blood iron levels.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Written informed consent signed prior to inclusion in the study;
• Women 18-55 years;
• Ability to understand the nature and the purpose of the study, including possible risks and side effects;
• Cability to collaborate with the investigator and meet the requirements of the entire study

Exclusion Criteria:

• Smoke
• 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 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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBSA Iron ODF; A single dose of IBSA Iron ODF containing 30mg Iron and 400ug folic acid will be admistered to healthy female volounteers in one of the two consecutive study periods with a 7-day washout interval between the two administrations.	Dietary supplement: IBSA Iron ODF; IBSA Iron ODF is a food supplement based on ferric pyrophosphate and folic acid in orodispersible film. IBSA Iron ODF appears as a yellow, opaque, homogeneous film, without visible particles. Once taken, it dissolves on the tongue and can be swallowed without adding water.
Active Comparator: SiderAL® FORTE; A single dose of SiderAL® FORTE containing 30mg Iron and 70mg vitamin C will be admistered to healthy female volounteers in one of the two consecutive study periods with a 7-day washout interval between the two administrations.	Dietary supplement: SiderAL® FORTE; Sideral® r.m. contained in SiderAL® FORTE is an iron protected with Sucrosomial® Technology which passes through the gastric environment intact and is absorbed in the intestine, thus preventing any irritation and discomfort to the stomach. The presence of Vitamin C facilitates the absorption of iron.; Other Names: Sucrosomial iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration of serum Iron	Maximum plasma concentration (Cmax) of serum iron to evaluate the rate of absorption of iron after a single oral dose of test versus reference	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Tmax of serum iron	Time to achieve Cmax (Tmax) after a single oral dose of test versus reference	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
AUC0-8 of serum iron	Evaluation of area under the curve of serum iron up to 8h post-administration to evaluate the extent of iron absorption after a single oral dose of test versus reference	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood concentration of hemoglobin	Evalution of the change from baseline of hemoglobin after administration of test versus reference product	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of hematocrit	Evalution of the change from baseline of hematocrit after administration of test versus reference product	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of ferritin	Evalution of the change from baseline of ferritin after administration of test versus reference product	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of transferrin	Evalution of the change from baseline of transferrin after administration of test versus reference product	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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	-24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour

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): November 25, 2022
• Primary Completion (Actual): December 3, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: IBSAFE_PK22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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