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Sucrosomial Iron in Patients With Celiac Disease and IDA

Primary Purpose

Celiac Disease, Iron Deficiency Anemia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sucrosomial iron
Sulphate iron
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • proven celiac disease
  • iron deficiency anemia

Exclusion Criteria:

  • other autoimmne diseases
  • pregnancy psychiatric disorders

Sites / Locations

  • Fondazione IRCCS Ca' GrandaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sulphate iron

sucrosomial iron

Arm Description

patients administered with sulphate iron

patients administered with sucrosomial iron

Outcomes

Primary Outcome Measures

Hemoglobin

Secondary Outcome Measures

Full Information

First Posted
September 21, 2016
Last Updated
March 23, 2017
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT02916654
Brief Title
Sucrosomial Iron in Patients With Celiac Disease and IDA
Official Title
Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sulphate iron
Arm Type
Active Comparator
Arm Description
patients administered with sulphate iron
Arm Title
sucrosomial iron
Arm Type
Experimental
Arm Description
patients administered with sucrosomial iron
Intervention Type
Dietary Supplement
Intervention Name(s)
sucrosomial iron
Intervention Description
administration of sucrosomial iron
Intervention Type
Drug
Intervention Name(s)
Sulphate iron
Intervention Description
administration of sulphate iron
Primary Outcome Measure Information:
Title
Hemoglobin
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: proven celiac disease iron deficiency anemia Exclusion Criteria: other autoimmne diseases pregnancy psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Elli, MD
Phone
0255033384
Ext
0039
Email
dottorlucaelli@gmail.com
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Elli, MD
Phone
0255033384
Ext
0039
Email
dottorlucaelli@gmail.com

12. IPD Sharing Statement

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Sucrosomial Iron in Patients With Celiac Disease and IDA

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