Suspended

Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate

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What is being tested

sucrosomial iron

+ Sulphate iron

Dietary SupplementDrug
Who is being recruted

Iron Deficiencies+11

+ Anemia

+ Anemia, Hypochromic

From 18 to 75 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2015
See protocol details

Summary

Principal SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ContactLuca Elli, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleSucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
Principal SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ContactLuca Elli, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesAnemiaAnemia, HypochromicCeliac DiseaseDigestive System DiseasesGastrointestinal DiseasesHematologic DiseasesHemic and Lymphatic DiseasesIntestinal DiseasesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, Iron-DeficiencyIron Metabolism Disorders

Criteria

2 inclusion criteria required to participate
proven celiac disease

iron deficiency anemia

2 exclusion criteria prevent from participating
other autoimmne diseases

pregnancy psychiatric disorders

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
patients administered with sucrosomial iron

Group II

Active Comparator
patients administered with sulphate iron

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fondazione IRCCS Ca' Granda

Milan, ItalyOpen Fondazione IRCCS Ca' Granda in Google Maps
SuspendedOne Study Center