Sucrosomial Iron in Patients With Celiac Disease and IDA

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02916654
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease; Iron Deficiency Anemia	Dietary Supplement: sucrosomial iron; Drug: Sulphate iron	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sulphate iron patients administered with sulphate iron	Drug: Sulphate iron; administration of sulphate iron
Experimental: sucrosomial iron patients administered with sucrosomial iron	Dietary Supplement: sucrosomial iron; administration of sucrosomial iron

Outcome Measures

Primary Outcome Measures

1. Hemoglobin [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• proven celiac disease

• iron deficiency anemia

Exclusion Criteria:

• other autoimmne diseases

• pregnancy psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Ca' Granda	Milano	MI	Italy	20122

Sponsors and Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• ClinicalTrials.gov Identifier: NCT02916654
• Other Study ID Numbers: 33_2014
• First Posted: Sep 27, 2016
• Last Update Posted: Mar 27, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Celiac Disease; Anemia, Iron-Deficiency; Iron

Study Results

No Results Posted as of Mar 27, 2017