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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02949765

Enrollment

Registered

2016-10-31

Start date

2015-12-31

Completion date

2017-09-30

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease, Iron Deficiency (Without Anemia)

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.

Interventions

DRUGIron sulfate 105 mg

Daily supplementation with iron sulfate 105 mg 1 pill/day

DIETARY_SUPPLEMENTIron-rich diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Ferritin levels (ng/mL) increase > 95% compared to basal levels	12 weeks

Secondary

Measure	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	12 weeks

Other

Measure	Time frame
Degree of compliance to therapy assessed through telephone interviews (number of pills taken)	12 weeks
Degree of compliance to diet assessed through compliance questionnaires (mg of irons ingested)	12 weeks
Number of participants with treatment-related adverse events assessed through NRS (number rating scales)	12 weeks

Countries

Italy

Contacts

Primary ContactFrancesca Ferretti, MD

francesca.ferretti01@gmail.com0039 0255033384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026