- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916654
Sucrosomial Iron in Patients With Celiac Disease and IDA
March 23, 2017 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luca Elli, MD
- Phone Number: 0039 0255033384
- Email: dottorlucaelli@gmail.com
Study Locations
-
-
MI
-
Milano, MI, Italy, 20122
- Recruiting
- Fondazione IRCCS Ca' Granda
-
Contact:
- Luca Elli, MD
- Phone Number: 0039 0255033384
- Email: dottorlucaelli@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- proven celiac disease
- iron deficiency anemia
Exclusion Criteria:
- other autoimmne diseases
- pregnancy psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sulphate iron
patients administered with sulphate iron
|
administration of sulphate iron
|
Experimental: sucrosomial iron
patients administered with sucrosomial iron
|
administration of sucrosomial iron
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
September 21, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 23, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33_2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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