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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02916654
Other study ID # 33_2014
Secondary ID
Status Recruiting
Phase N/A
First received September 21, 2016
Last updated March 23, 2017
Start date April 2015
Est. completion date December 2017

Study information

Verified date March 2017
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Luca Elli, MD
Phone 0255033384
Email dottorlucaelli@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- proven celiac disease

- iron deficiency anemia

Exclusion Criteria:

- other autoimmne diseases

- pregnancy psychiatric disorders

Study Design


Intervention

Dietary Supplement:
sucrosomial iron
administration of sucrosomial iron
Drug:
Sulphate iron
administration of sulphate iron

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Milano MI

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemoglobin 3 months
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