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Trial record 25 of 103 for:    celiac disease | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02949765
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Francesca Ferretti, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.


Condition or disease Intervention/treatment Phase
Celiac Disease Iron Deficiency (Without Anemia) Drug: Iron sulfate 105 mg Dietary Supplement: Iron-rich diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
Study Start Date : December 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease Iron

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



Primary Outcome Measures :
  1. Ferritin levels (ng/mL) increase > 95% compared to basal levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Hemoglobin levels (g/dL), compared to basal levels [ Time Frame: 12 weeks ]
  2. Iron levels (mcd/dl), compared to basal levels [ Time Frame: 12 weeks ]
  3. Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels [ Time Frame: 12 weeks ]

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


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949765


Contacts
Contact: Francesca Ferretti, MD 0039 0255033384 francesca.ferretti01@gmail.com

Locations
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Francesca Ferretti, MD    0039 0255033384    francesca.ferretti01@gmail.com   
Sub-Investigator: Luca Elli, MD, PhD         
Sub-Investigator: Federica Branchi, MD         
Sponsors and Collaborators
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.

Responsible Party: Francesca Ferretti, MD, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02949765     History of Changes
Other Study ID Numbers: Atto 302/2016
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Celiac Disease
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Malabsorption Syndromes
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs