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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02949765
Other study ID # Atto 302/2016
Secondary ID
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
Health authority
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

Study Design


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
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