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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Celiac Disease Iron Deficiency (Without Anemia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron sulfate 105 mg

Iron sulfate 105 mg: 1 pill/day is administered

Group Type ACTIVE_COMPARATOR

Iron sulfate 105 mg

Intervention Type DRUG

Daily supplementation with iron sulfate 105 mg 1 pill/day

Iron-rich diet

Iron-rich diet recommendations are given

Group Type EXPERIMENTAL

Iron-rich diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Iron sulfate 105 mg

Daily supplementation with iron sulfate 105 mg 1 pill/day

Intervention Type DRUG

Iron-rich diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Francesca Ferretti, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesca Francesca, MD

Role: PRINCIPAL_INVESTIGATOR

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