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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron sulfate 105 mg | Active Comparator | Iron sulfate 105 mg: 1 pill/day is administered |
|
| Iron-rich diet | Experimental | Iron-rich diet recommendations are given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sulfate 105 mg | Drug | Daily supplementation with iron sulfate 105 mg 1 pill/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin levels (ng/mL) increase > 95% compared to basal levels | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Ferretti, MD | Contact | 0039 0255033384 | francesca.ferretti01@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Milan | 20122 | Italy |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| Iron-rich diet |
| Dietary Supplement |
|
| 12 weeks |
| Degree of compliance to diet assessed through compliance questionnaires (mg of irons ingested) | 12 weeks |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019189 | Iron Metabolism Disorders |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |