Sucrosomial Iron in Patients With Celiac Disease and IDA | NCT02916654

Studies
Sucrosomial Iron in Patients With Celiac Disease and IDA

NCT02916654

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Unknown status

Last Update Posted

Mar 27, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Celiac Disease
Iron Deficiency Anemia

Interventions

sucrosomial iron
Sulphate iron

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Aug 2016Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Sep 21, 2016

First Submission Date that Met QC Criteria

Sep 23, 2016

First Posted Date

Sep 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2017

Last Update Posted Date

Mar 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sulphate iron	Active Comparator	patients administered with sulphate iron	Drug: Sulphate iron
sucrosomial iron	Experimental	patients administered with sucrosomial iron	Dietary Supplement: sucrosomial iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sucrosomial iron	Dietary Supplement	administration of sucrosomial iron	sucrosomial iron

Measure	Description	Time Frame
Hemoglobin		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

proven celiac disease
iron deficiency anemia

Exclusion Criteria:

other autoimmne diseases
pregnancy psychiatric disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luca Elli, MD	Contact	0255033384	0039	dottorlucaelli@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Ca' Granda	Recruiting	Milan	MI	20122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D002446	Celiac Disease
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718012	sucrosomial iron

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided