Iron DeficienciesNCT05989984
Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia
A study testing ODF Iron Supplement and Iron Supplement in Capsules in people with Iron Deficiencies, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- ODF Iron Supplement and Iron Supplement in Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2023to 8 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, Italy, 00128
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Deficiencies
- Being tested
- ODF Iron Supplement, Iron Supplement in Capsules
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODF Iron SupplementDietary supplement
ODF iron supplement will be admistered daily for 8 weeks.
Iron Supplement in CapsulesDietary supplement
Also called Sucrosomial iron
Iron supplement in capsule will be admistered daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ODF Iron Supplement | Experimental | ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid. Receives: Dietary Supplement: ODF Iron Supplement |
| Iron Supplement in Capsule | Active comparator | Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C. Receives: Dietary Supplement: Iron Supplement in Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement
Measured: Day 0, Week 8
Secondary outcomes (9)
Change from baseline in blood concentration of hemoglobin with test product
Change from baseline in blood concentration of hemoglobin after 4 weeks of supplementation with test product
Measured: Day 0, Week 4
Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with Iron supplement in capsule
Measured: Day 0, Week4, Week 8
Change from baseline in blood concentration of hematocrit
Evalution of the change from baseline of hematocrit after administration of test versus reference product
Measured: Day 0, Week4, Week 8
Change from baseline in blood concentration of ferritin
Evalution of the change from baseline of ferritin after administration of test versus reference product
Measured: Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin
Evalution of the change from baseline of transferrin after administration of test versus reference product
Measured: Day 0, Week4, Week 8
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
Measured: Day 0, Week4, Week 8
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
Measured: Day 0, Week4, Week 8
Change from baseline in blood concentration of serum iron
Evalution of the change from baseline of serum iron after administration of test versus reference product
Measured: Day 0, Week4, Week 8
Change from baseline in mean corpuscolar volume (MCV)
Evalution of the change from baseline of MCV after administration of test versus reference product
Measured: Day 0, Week4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start29 Jul 2023
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, prospective, randomized study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Informapro Srl
- Responsible party
- Sponsor
- Investigators
- Silvia Angeletti, Principal investigator, Operative Research Unit of Clinical Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989984
- Sponsor's protocol ID
- IBSAFE_CLI22
- Status last verified
- Jan 2025
- First submitted
- 4 Aug 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05989984
- Acronym / sponsor ID
- IBSAFE_CLI22
- Conditions
- Iron Deficiencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Collaborators
- Informapro Srl
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, prospective, randomized study
| Arm | Type | Receives |
|---|---|---|
| ODF Iron Supplement | Experimental | Dietary Supplement: ODF Iron SupplementODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid. |
| Iron Supplement in Capsule | Active comparator | Dietary Supplement: Iron Supplement in CapsulesIron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODF Iron SupplementODF iron supplement will be admistered daily for 8 weeks. | Dietary supplement | ODF Iron Supplement |
| Iron Supplement in CapsulesAlso: Sucrosomial ironIron supplement in capsule will be admistered daily for 8 weeks. | Dietary supplement | Iron Supplement in Capsule |
Primary outcome
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
9 secondary outcomes
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 with Iron supplement in capsule (reference product)
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of hematocrit
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of ferritin
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of transferrin receptor
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of folic acid
Time frame: Day 0, Week4, Week 8
Change from baseline in blood concentration of serum iron
Time frame: Day 0, Week4, Week 8
Change from baseline in mean corpuscolar volume (MCV)
Time frame: Day 0, Week4, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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Iron Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Angeletti principal investigator
Operative Research Unit of Clinical Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ODF Iron Supplement and Iron Supplement in Capsules in people with Iron Deficiencies, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product) (time frame: Day 0, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.