Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease
Not Applicable
- Conditions
- Celiac DiseaseIron Deficiency (Without Anemia)
- Interventions
- Dietary Supplement: Iron-rich diet
- Registration Number
- NCT02949765
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 35
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron-rich diet Iron-rich diet Iron-rich diet recommendations are given Iron sulfate 105 mg Iron sulfate 105 mg Iron sulfate 105 mg: 1 pill/day is administered
- Primary Outcome Measures
Name Time Method Ferritin levels (ng/mL) increase > 95% compared to basal levels 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy