Iron Deficiency and TTG Normalization

NCT ID: NCT05675280

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2022-04-01

Brief Summary

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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

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Conditions

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Celiac Disease in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Iron deficiency at diagnosis

Gluten free diet

Intervention Type OTHER

All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study

No iron deficiency at diagnosis

Gluten free diet

Intervention Type OTHER

All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study

Interventions

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Gluten free diet

All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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eyal zifman

Head of pediatric gastroenterology service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eyal Zifman, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir medical center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MMC-20-0021

Identifier Type: -

Identifier Source: org_study_id

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