Iron Deficiency and TTG Normalization | NCT05675280

Studies
Iron Deficiency and TTG Normalization

NCT05675280

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

Jan 11, 2023Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Celiac Disease in Children

Interventions

Gluten free diet

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2020Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Dec 29, 2022

First Submission Date that Met QC Criteria

Dec 29, 2022

First Posted Date

Jan 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iron deficiency at diagnosis			Other: Gluten free diet
No iron deficiency at diagnosis			Other: Gluten free diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten free diet	Other	All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study	Iron deficiency at diagnosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TTG normalization	normalization of tissue transglutaminase antibody	1 year from gluten free diet initiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric patients diagnosed with Celiac disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eyal Zifman, MD	Meir Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir medical center		Kfar Saba			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055050	Diet, Gluten-Free

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

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Browse Branches

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