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

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660200
• Other study ID #: IBSAFE_PK22
• Status: Completed
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: IBSA Farmaceutici Italia Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 31, 2022
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma	Roma

Sponsors (2)

Lead Sponsor	Collaborator
IBSA Farmaceutici Italia Srl	Informapro Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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