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

NCT02949765 | Unknown

• 1 other identifier: Atto 302/2016
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Iron Deficiency (Without Anemia)

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (3)

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

  12 weeks

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

  12 weeks

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

  12 weeks

Other Outcomes (3)

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

Iron sulfate 105 mg

ACTIVE COMPARATOR

Iron sulfate 105 mg: 1 pill/day is administered

Drug: Iron sulfate 105 mg

Iron-rich diet

EXPERIMENTAL

Iron-rich diet recommendations are given

Dietary Supplement: Iron-rich diet

Interventions

Iron sulfate 105 mg DRUG

Daily supplementation with iron sulfate 105 mg 1 pill/day

Iron sulfate 105 mg

Iron-rich diet DIETARY_SUPPLEMENT

Iron-rich diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Celiac Disease; Iron Deficiencies

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Iron Metabolism Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Ferretti, MD

CONTACT

0039 0255033384; francesca.ferretti01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 31, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)