Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules
- Conditions
- Iron-deficiency
- Interventions
- Dietary Supplement: SiderAL® FORTEDietary Supplement: IBSA Iron ODF
- Registration Number
- NCT05660200
- Lead Sponsor
- IBSA Farmaceutici Italia Srl
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SiderAL® FORTE 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. IBSA Iron ODF 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.
- Primary Outcome Measures
Name Time Method AUC0-8 of serum iron -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
Maximum plasma concentration of serum Iron -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 -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
- Secondary Outcome Measures
Name Time Method Change from baseline in blood concentration of transferrin -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour Evalution of the change from baseline of transferrin after administration of test versus reference product
Change from baseline in blood concentration of folic acid -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour Evalution of the change from baseline of folic acid after administration of test versus reference product
Change from baseline in blood concentration of hematocrit -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour Evalution of the change from baseline of hematocrit after administration of test versus reference product
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 Evalution of the change from baseline of transferrin receptor after administration of test versus reference product
Change from baseline in blood concentration of hemoglobin -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour Evalution of the change from baseline of hemoglobin after administration of test versus reference product
Change from baseline in blood concentration of ferritin -24 hour, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour Evalution of the change from baseline of ferritin after administration of test versus reference product
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
🇮🇹Roma, Italy