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Trial record 33 of 100 for:    celiac disease | Recruiting, Not yet recruiting, Available Studies

Sucrosomial Iron in Patients With Celiac Disease and IDA

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ClinicalTrials.gov Identifier: NCT02916654
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Celiac Disease Iron Deficiency Anemia Dietary Supplement: sucrosomial iron Drug: Sulphate iron Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease Iron

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




Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • proven celiac disease
  • iron deficiency anemia

Exclusion Criteria:

  • other autoimmne diseases
  • pregnancy psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916654


Contacts
Contact: Luca Elli, MD 0255033384 ext 0039 dottorlucaelli@gmail.com

Locations
Italy
Fondazione IRCCS Ca' Granda Recruiting
Milano, MI, Italy, 20122
Contact: Luca Elli, MD    0255033384 ext 0039    dottorlucaelli@gmail.com   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02916654     History of Changes
Other Study ID Numbers: 33_2014
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Celiac Disease
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Malabsorption Syndromes
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs