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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05675280
Other study ID # MMC-20-0021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2020
Est. completion date April 1, 2022

Study information

Verified date January 2023
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date April 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Meir medical center Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary TTG normalization normalization of tissue transglutaminase antibody 1 year from gluten free diet initiation
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