NCT02916654

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

September 21, 2016

Last Update Submit

March 23, 2017

Conditions

Celiac DiseaseIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    3 months

Study Arms (2)

sulphate iron

ACTIVE COMPARATOR

patients administered with sulphate iron

Drug: Sulphate iron

sucrosomial iron

EXPERIMENTAL

patients administered with sucrosomial iron

Dietary Supplement: sucrosomial iron

Interventions

sucrosomial ironDIETARY_SUPPLEMENT

administration of sucrosomial iron

sucrosomial iron
Sulphate ironDRUG

administration of sulphate iron

sulphate iron

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proven celiac disease
  • iron deficiency anemia

You may not qualify if:

  • other autoimmne diseases
  • pregnancy psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda

Milan, MI, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Celiac DiseaseAnemia, Iron-Deficiency

Interventions

sucrosomial iron

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism Disorders

Central Study Contacts

Luca Elli, MD

CONTACT

0255033384dottorlucaelli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 27, 2016

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

IT(1)