NCT05660200

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: IBSA Farmaceutici Italia Srl · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	IBSA Iron ODF	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.
DIETARY_SUPPLEMENT	SiderAL® FORTE	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.

Timeline

• Start date: 2022-11-25
• Primary completion: 2022-12-03
• Completion: 2022-12-31
• First posted: 2022-12-21
• Last updated: 2023-01-11

Locations

1 site across 1 country: Italy