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

NCT05660200 | Completed

• 1 other identifier: IBSAFE_PK22
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change from baseline in blood concentration of hemoglobin

  -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour

• Change from baseline in blood concentration of hematocrit

  -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour

• Change from baseline in blood concentration of ferritin

  -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour

• Change from baseline in blood concentration of transferrin

  -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

  -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour

Study Arms (2)

IBSA Iron ODF

EXPERIMENTAL

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

SiderAL® FORTE

ACTIVE COMPARATOR

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

Interventions

IBSA Iron ODF 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.

IBSA Iron ODF

SiderAL® FORTE 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.

Also known as: Sucrosomial iron

SiderAL® FORTE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Informapro Srl: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico di Roma

Roma, 00128, Italy

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

sucrosomial iron

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Silvia Angeletti

  Operative Research Unit of Clinical Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking procedure will be applied
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose, open-label, randomized, double-arm cross-over study

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 21, 2022
• Study Start: November 25, 2022
• Primary Completion: December 3, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)