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

March 11, 2017 updated by: Francesca Ferretti, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Contact:
        • Sub-Investigator:
          • Luca Elli, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iron sulfate 105 mg
Iron sulfate 105 mg: 1 pill/day is administered
Drug: Iron sulfate 105 mg
Daily supplementation with iron sulfate 105 mg 1 pill/day
Experimental: Iron-rich diet
Iron-rich diet recommendations are given
Dietary supplement: Iron-rich diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ferritin levels (ng/mL) increase > 95% compared to basal levels
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin levels (g/dL), compared to basal levels
Time Frame: 12 weeks
12 weeks
Iron levels (mcd/dl), compared to basal levels
Time Frame: 12 weeks
12 weeks
Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events assessed through NRS (number rating scales)
Time Frame: 12 weeks
12 weeks
Degree of compliance to therapy assessed through telephone interviews (number of pills taken)
Time Frame: 12 weeks
12 weeks
Degree of compliance to diet assessed through compliance questionnaires (mg of irons ingested)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Francesca Francesca, MD, Gastroenterology and Endoscopy Unit Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Department of Pathophysiology and Transplantation Università degli Studi di Milano - Italy.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 11, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atto 302/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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