Iron Deficiency and TTG Normalization

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT05675280

Collaborator

(none)

118

Enrollment

Location

25.3

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease in Children	Other: Gluten free diet

Study Design

Study Type:

Observational

Actual Enrollment :

118 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 20, 2020

Actual Primary Completion Date :

Mar 1, 2022

Actual Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Iron deficiency at diagnosis	Other: Gluten free diet All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study
No iron deficiency at diagnosis	Other: Gluten free diet All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study

Arm

Intervention/Treatment

Iron deficiency at diagnosis

Other: Gluten free diet

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

No iron deficiency at diagnosis

Other: Gluten free diet

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

Outcome Measures

Primary Outcome Measures

TTG normalization [1 year from gluten free diet initiation]
normalization of tissue transglutaminase antibody

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir medical center	Kfar Saba		Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator: Eyal Zifman, MD, Meir Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

eyal zifman, Head of pediatric gastroenterology service, Meir Medical Center

ClinicalTrials.gov Identifier:

NCT05675280

Other Study ID Numbers:

MMC-20-0021

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 11, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Celiac Disease

Study Results

No Results Posted as of Jan 11, 2023