Celiac Disease in Children Clinical Trial
Official title:
The Association Between Iron Deficiency at Diagnosis, Female Sex and Tissue Transglutaminase Antibody Normalization in Pediatric Celiac Disease
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 |
Verified date | January 2023 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Israel | Meir medical center | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
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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