- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949765
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francesca Ferretti, MD
- Phone Number: 0039 0255033384
- Email: francesca.ferretti01@gmail.com
Study Locations
-
-
-
Milan, Italy, 20122
- Recruiting
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
-
Contact:
- Francesca Ferretti, MD
- Phone Number: 0039 0255033384
- Email: francesca.ferretti01@gmail.com
-
Sub-Investigator:
- Luca Elli, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Daily supplementation with iron sulfate 105 mg 1 pill/day
|
Experimental: Iron-rich diet
Iron-rich diet recommendations are given
|
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
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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