NCT05675280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

December 29, 2022

Last Update Submit

January 10, 2023

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (1)

  • TTG normalization

    normalization of tissue transglutaminase antibody

    1 year from gluten free diet initiation

Study Arms (2)

Iron deficiency at diagnosis

Other: Gluten free diet

No iron deficiency at diagnosis

Other: Gluten free diet

Interventions

Gluten free dietOTHER

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

Iron deficiency at diagnosisNo iron deficiency at diagnosis

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients diagnosed with Celiac disease

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

Location

MeSH Terms

Interventions

Diet, Gluten-Free

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eyal Zifman, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of pediatric gastroenterology service

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 9, 2023

Study Start

February 20, 2020

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)