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OpenTrials
Completed

NCT Number: NCT05675280

Iron Deficiency and TTG Normalization

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.

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Key information

Conditions

Celiac Disease in Children

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir medical center

Kfar Saba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gluten free diet

Other

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

Primary outcomes

  1. TTG normalization

    Time frame: 1 year from gluten free diet initiation

    normalization of tissue transglutaminase antibody

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

The Association Between Iron Deficiency at Diagnosis, Female Sex and Tissue Transglutaminase Antibody Normalization in Pediatric Celiac Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2023
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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