Sucrosomial Iron in Patients With Celiac Disease and IDA

Not Applicable

• Conditions: Celiac Disease; Iron Deficiency Anemia
• Interventions: Drug: Sulphate iron; Dietary Supplement: sucrosomial iron

• Registration Number: NCT02916654
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which shows a high gastrointestinal absorption and high bioavailability with a low incidence of side effects due to lack of any direct contact with intestinal mucosa. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in CD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-08
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• proven celiac disease
• iron deficiency anemia

Exclusion Criteria

• other autoimmne diseases
• pregnancy psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sulphate iron	Sulphate iron	patients administered with sulphate iron
sucrosomial iron	sucrosomial iron	patients administered with sucrosomial iron

Primary Outcome Measures

Name	Time	Method
Hemoglobin	3 months

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda; 🇮🇹 Milano, MI, Italy