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

NCT ID: NCT05660200

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2022-12-31

Brief 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.

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.

Conditions

Iron-deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IBSA Iron ODF

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: ACTIVE_COMPARATOR

SiderAL® FORTE

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Sucrosomial iron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Informapro Srl

OTHER

Sponsor Role: collaborator

IBSA Farmaceutici Italia Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Angeletti

Role: PRINCIPAL_INVESTIGATOR

Operative Research Unit of Clinical Laboratory

Locations

Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Roma, , Italy

Countries

Italy

Other Identifiers

IBSAFE_PK22

Identifier Type: -

Identifier Source: org_study_id