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Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

Primary Purpose

Celiac Disease, Iron Deficiency (Without Anemia)

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Iron sulfate 105 mg

Iron-rich diet

About this trial

This is an interventional treatment trial for Celiac Disease

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Celiac patients on gluten free diet since 1 year
iron deficiency (ferritin <15 ng/L or ferritin 15-20 + transferrin saturation <15%)

Exclusion Criteria:

allergy to iron supplementation
anemia
pregnancy or breastfeeding
menopause
organic or psychiatric diseases

Sites / Locations

Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Iron sulfate 105 mg

Iron-rich diet

Arm Description

Iron sulfate 105 mg: 1 pill/day is administered

Iron-rich diet recommendations are given

Outcomes

Primary Outcome Measures

Ferritin levels (ng/mL) increase > 95% compared to basal levels

Secondary Outcome Measures

Hemoglobin levels (g/dL), compared to basal levels

Iron levels (mcd/dl), compared to basal levels

Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels

Full Information

NCT ID

NCT02949765

First Posted

September 21, 2016

Last Updated

March 11, 2017

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

1. Study Identification

Unique Protocol Identification Number

NCT02949765

Brief Title

Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

Official Title

Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good compliance and clinical response to gluten-free diet. These patients are usually premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not balanced. The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not tolerated, and a dietary approach through a iron-rich diet in this subset of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease, Iron Deficiency (Without Anemia)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iron sulfate 105 mg

Arm Type

Active Comparator

Arm Description

Iron sulfate 105 mg: 1 pill/day is administered

Arm Title

Iron-rich diet

Arm Type

Experimental

Arm Description

Iron-rich diet recommendations are given

Intervention Type

Drug

Intervention Name(s)

Iron sulfate 105 mg

Intervention Description

Daily supplementation with iron sulfate 105 mg 1 pill/day

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron-rich diet

Primary Outcome Measure Information:

Title

Ferritin levels (ng/mL) increase > 95% compared to basal levels

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Hemoglobin levels (g/dL), compared to basal levels

Time Frame

12 weeks

Title

Iron levels (mcd/dl), compared to basal levels

Time Frame

12 weeks

Title

Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Number of participants with treatment-related adverse events assessed through NRS (number rating scales)

Time Frame

12 weeks

Title

Degree of compliance to therapy assessed through telephone interviews (number of pills taken)

Time Frame

12 weeks

Title

Degree of compliance to diet assessed through compliance questionnaires (mg of irons ingested)

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Celiac patients on gluten free diet since 1 year iron deficiency (ferritin <15 ng/L or ferritin 15-20 + transferrin saturation <15%) Exclusion Criteria: allergy to iron supplementation anemia pregnancy or breastfeeding menopause organic or psychiatric diseases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesca Ferretti, MD

Phone

0039 0255033384

francesca.ferretti01@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesca Francesca, MD

Organizational Affiliation

Gastroenterology and Endoscopy Unit Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Department of Pathophysiology and Transplantation Università degli Studi di Milano - Italy.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

City

Milan

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francesca Ferretti, MD

Phone

0039 0255033384

francesca.ferretti01@gmail.com

First Name & Middle Initial & Last Name & Degree

Luca Elli, MD, PhD

First Name & Middle Initial & Last Name & Degree

Federica Branchi, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

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