Sucrosomial Iron in Patients With Celiac Disease and IDA

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Iron Deficiency Anemia; Celiac Disease

Treatments: Dietary Supplement: sucrosomial iron; Drug: Sulphate iron

Study type: Interventional

Funder types: Other

Identifiers

NCT02916654

33_2014

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• proven celiac disease
• iron deficiency anemia

Exclusion criteria

• other autoimmne diseases
• pregnancy psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

sulphate iron

Active Comparator group

Description:

patients administered with sulphate iron

Treatment:

Drug: Sulphate iron

sucrosomial iron

Experimental group

Description:

patients administered with sucrosomial iron

Treatment:

Dietary Supplement: sucrosomial iron