Iron-deficiencyNCT05660200
Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules
A study testing IBSA Iron ODF and SiderAL® FORTE in people with Iron-deficiency, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- IBSA Iron ODF and SiderAL® FORTE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 25 Nov 2022to 31 Dec 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Roma, 00128
About this study
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
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.
Read the 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
- Being tested
- IBSA Iron ODF, SiderAL® FORTE
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBSA Iron ODFDietary 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® FORTEDietary supplement
Also called Sucrosomial iron
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: SiderAL® FORTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: -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
Measured: -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
Measured: -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
Evalution of the change from baseline of hemoglobin after administration of test versus reference product
Measured: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of hematocrit
Evalution of the change from baseline of hematocrit after administration of test versus reference product
Measured: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of ferritin
Evalution of the change from baseline of ferritin after administration of test versus reference product
Measured: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of transferrin
Evalution of the change from baseline of transferrin after administration of test versus reference product
Measured: -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
Evalution of the change from baseline of transferrin receptor after administration of test versus reference product
Measured: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start25 Nov 2022
- Primary completion3 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Crossover
- Model description
- Single-dose, open-label, randomized, double-arm cross-over study
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT05660200
- Sponsor's protocol ID
- IBSAFE_PK22
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05660200
- Acronym / sponsor ID
- IBSAFE_PK22
- Conditions
- Iron-deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Collaborators
- Informapro Srl
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Dec 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-dose, open-label, randomized, double-arm cross-over study
| Arm | Type | Receives |
|---|---|---|
| IBSA Iron ODF | Experimental | Dietary Supplement: IBSA Iron ODFA 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. |
| SiderAL® FORTE | Active comparator | Dietary Supplement: SiderAL® FORTEA 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| IBSA Iron ODFIBSA 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. | Dietary supplement | IBSA Iron ODF |
| SiderAL® FORTEAlso: Sucrosomial ironSideral® 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. | Dietary supplement | SiderAL® FORTE |
Primary outcome
Maximum plasma concentration of serum Iron
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Maximum plasma concentration (Cmax) of serum iron to evaluate the rate of absorption of iron after a single oral dose of test versus reference
Tmax of serum iron
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Time to achieve Cmax (Tmax) after a single oral dose of test versus reference
AUC0-8 of serum iron
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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
6 secondary outcomes
Change from baseline in blood concentration of hemoglobin
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of hematocrit
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of ferritin
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of transferrin
Time frame: -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
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
Change from baseline in blood concentration of folic acid
Time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour
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 11 Jan 2023.
- Individual participant dataSharing planned: No
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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 IBSA Iron ODF and SiderAL® FORTE in people with Iron-deficiency, 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 4 inclusion and 11 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 11 Jan 2023. 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?
Maximum plasma concentration of serum Iron (time frame: -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour). The study lists 3 primary outcomes in all. 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 11 Jan 2023.