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

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Overall Status

Unknown status

CT.gov ID

NCT02949765

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ferritin levels (ng/mL) increase > 95% compared to basal levels [12 weeks]

Secondary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan		Italy	20122

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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francesca Ferretti, MD, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

ClinicalTrials.gov Identifier:

NCT02949765

Other Study ID Numbers:

Atto 302/2016

First Posted:

Oct 31, 2016

Last Update Posted:

Mar 14, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Celiac Disease

Anemia, Iron-Deficiency

Iron

Study Results

No Results Posted as of Mar 14, 2017