Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia

January 7, 2025 updated by: IBSA Farmaceutici Italia Srl

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
Time Frame: Day 0, Week 8
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement
Day 0, Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in blood concentration of hemoglobin with test product
Time Frame: Day 0, Week 4
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)
Time Frame: Day 0, Week4, Week 8
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
Time Frame: Day 0, Week4, Week 8
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
Time Frame: Day 0, Week4, Week 8
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
Time Frame: Day 0, Week4, Week 8
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
Time Frame: Day 0, Week4, Week 8
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
Time Frame: Day 0, Week4, Week 8
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
Time Frame: Day 0, Week4, Week 8
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)
Time Frame: Day 0, Week4, Week 8
Evalution of the change from baseline of MCV after administration of test versus reference product
Day 0, Week4, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IBSA Farmaceutici Italia Srl

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Informapro Srl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia Angeletti, Operative Research Unit of Clinical Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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