Iron Deficiency and TTG Normalization

Completed

• Conditions: Celiac Disease in Children
• Interventions: Other: Gluten free diet

• Registration Number: NCT05675280
• Lead Sponsor: Meir Medical Center

Brief Summary

The investigators conducted a retrospective, observational cohort study which enrolled CD subjects aged 2-18y, diagnosed between Jan 2016 and Dec 2020. Demographic and laboratory data were collected at diagnosis and 1y after adherence to GFD. ID was determined according to hemoglobin and ferritin levels. The investigators compared CD subjects with and without ID at CD diagnosis in relation to TTG normalization at 1y.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-20
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01
• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2022-12-29
• Status Verified: 2023-01
• Study First Posted: 2023-01-09
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Children (male and female) diagnosed with CD
• Age 2-18y

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Exclusion Criteria

• Total IgA deficiency
• Anemia due to other causes - anyone with anemia and normal or elevated ferritin levels (e.g. thalassemia, spherocytosis)
• Other chronic conditions increasing the risk of anemia or falsely elevated ferritin (e.g. inflammatory bowel disease, chronic kidney disease, infection)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iron deficiency at diagnosis	Gluten free diet	-
No iron deficiency at diagnosis	Gluten free diet	-

Primary Outcome Measures

Name	Time	Method
TTG normalization	1 year from gluten free diet initiation	normalization of tissue transglutaminase antibody

Trial Locations

Locations (1)

Meir medical center; 🇮🇱 Kfar Saba, Israel