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Status unknownNCT02916654Updated Mar 27, 2017

Sucrosomial Iron in Patients With Celiac Disease and IDA

An interventional study of sucrosomial iron and Sulphate iron in Celiac Disease and Iron Deficiency Anemia, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Celiac Disease
  • Iron Deficiency Anemia
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In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • proven celiac disease
  • iron deficiency anemia

Exclusion criteria

Exclusion Criteria:

  • other autoimmne diseases
  • pregnancy psychiatric disorders
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    sulphate iron

    patients administered with sulphate iron

    Drug: Sulphate iron

  • Experimental
    sucrosomial iron

    patients administered with sucrosomial iron

    Dietary Supplement: sucrosomial iron

Interventions

  • Dietary supplementsucrosomial iron

    administration of sucrosomial iron

  • DrugSulphate iron

    administration of sulphate iron

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What researchers measure

Primary outcomes

  1. Hemoglobin

    Time frame: 3 months

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Study locations

1 of 1 sites recruiting
  • Fondazione IRCCS Ca' Granda
    Milano, MI 20122, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02916654
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Sponsor
First posted
Sep 27, 2016
Start date
Apr 2015
Primary completion
Aug 2016
Completion
Dec 2017 (estimated)
Last update
Mar 27, 2017

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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