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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Iron Deficiency (Without Anemia); Celiac Disease

Treatments: Drug: Iron sulfate 105 mg; Dietary Supplement: Iron-rich diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02949765

Atto 302/2016

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Iron sulfate 105 mg

Active Comparator group

Description:

Iron sulfate 105 mg: 1 pill/day is administered

Treatment:

Drug: Iron sulfate 105 mg

Iron-rich diet

Experimental group

Description:

Iron-rich diet recommendations are given

Treatment:

Dietary Supplement: Iron-rich diet