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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02949765
• Other study ID #: Atto 302/2016
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2016
• Last updated: March 11, 2017
• Start date: December 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Francesca Ferretti, MD
• Phone: 0039 0255033384
• Email: francesca.ferretti01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Celiac Disease
• Iron Deficiency (Without Anemia)

Intervention

Drug:
• Iron sulfate 105 mg
Daily supplementation with iron sulfate 105 mg 1 pill/day

Dietary Supplement:
• Iron-rich diet

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events assessed through NRS (number rating scales)		12 weeks
Other	Degree of compliance to therapy assessed through telephone interviews (number of pills taken)		12 weeks
Other	Degree of compliance to diet assessed through compliance questionnaires (mg of irons ingested)		12 weeks
Primary	Ferritin levels (ng/mL) increase > 95% compared to basal levels		12 weeks
Secondary	Hemoglobin levels (g/dL), compared to basal levels		12 weeks
Secondary	Iron levels (mcd/dl), compared to basal levels		12 weeks
Secondary	Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels		12 weeks