Celiac DiseaseNCT02916654
Sucrosomial Iron in Patients With Celiac Disease and IDA
A study testing sucrosomial iron and Sulphate iron in people with Celiac Disease and Iron Deficiency Anemia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease, Iron Deficiency Anemia
- What is being tested?
- sucrosomial iron and Sulphate iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proven celiac disease
- iron deficiency anemia
Who cannot join
- other autoimmne diseases
- pregnancy psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda
Milan, MI, 20122
Luca Elli, MD, 0255033384 ext. 0039, dottorlucaelli@gmail.com
About this study
Official title: 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.
- Conditions
- Celiac Disease, Iron Deficiency Anemia
- Being tested
- sucrosomial iron, Sulphate iron
- Medical subject headings
- Celiac Disease, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucrosomial ironDietary supplement
administration of sucrosomial iron
Sulphate ironDrug
administration of sulphate iron
| Study group | Role | What they receive |
|---|---|---|
| sulphate iron | Active comparator | patients administered with sulphate iron Receives: Drug: Sulphate iron |
| sucrosomial iron | Experimental | patients administered with sucrosomial iron Receives: Dietary Supplement: sucrosomial iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916654
- Sponsor's protocol ID
- 33_2014
- Status last verified
- Mar 2017
- First submitted
- 21 Sep 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
- ClinicalTrials.gov ID
- NCT02916654
- Acronym / sponsor ID
- 33_2014
- Conditions
- Celiac Disease, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sulphate iron | Active comparator | Drug: Sulphate ironpatients administered with sulphate iron |
| sucrosomial iron | Experimental | Dietary Supplement: sucrosomial ironpatients administered with sucrosomial iron |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- proven celiac disease
- iron deficiency anemia
Key exclusion criteria (2 listed)
- other autoimmne diseases
- pregnancy psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucrosomial ironadministration of sucrosomial iron | Dietary supplement | sucrosomial iron |
| Sulphate ironadministration of sulphate iron | Drug | sulphate iron |
Primary outcome
Hemoglobin
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrosomial iron and Sulphate iron in people with Celiac Disease and Iron Deficiency Anemia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Elli, MD (0255033384 ext. 0039, dottorlucaelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.