Physical Fitness in Celiac Disease Patients - the Effect... | NCT04012736

Studies
Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet

NCT04012736

Sponsor

Meir Medical Center

Status

Terminated

Last Update Posted

Aug 26, 2022Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Celiac Disease in Children

Interventions

Not provided

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to recruit and perform study visits due to COVID19 pandemic

Expanded Access Info

Start Date

Aug 13, 2019Actual

Primary Completion Date

Apr 5, 2022Actual

Completion Date

Apr 5, 2022Actual

First Submitted Date

Jun 24, 2019

First Submission Date that Met QC Criteria

Jul 7, 2019

First Posted Date

Jul 9, 2019Actual

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

Aug 23, 2022

Last Update Posted Date

Aug 26, 2022Actual

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

Evaluating the effect of Celiac disease (CD) and gluten free diet (GFD) on physical fitness parameters among CD subjects. The CD subjects will be compared to healthy controls.

Detailed Description

This is a prospective observational cohort study. The study would take place at Meir Medical Center (Kfar-Saba, Israel), a secondary-level academic hospital. The investigators will enroll 50 newly diagnosed CD subjects. The diagnosis will be in accordance with the European Society for Gastroenterology Hepatology and Nutrition guidelines for the diagnosis of CD from 2012 (6). The investigators will also enroll 50 control subjects. The control subjects are children visiting the pediatric gastroenterology clinic. Before enrollment the investigators will rule out chronic conditions involving the gastrointestinal tract including CD.

All subjects will be enrolled after providing an informed consent and signing the consent form.

The investigators will obtain the following measurements and evaluations at and 6 months after enrollment:

Anthropometric measurements: Height, weight, body mass index (BMI) and total body fat will be evaluated using a TANITA scale. The z-score for each parameter will be recorded.
A Godin leisure-time exercise questionnaire (7) will be filled by the subjects and their parents
Evaluation of physical fitness by the Eurofit fitness testing (8). This series of physical fitness tests was developed to evaluate speed, stamina and strength in school-aged children.
1. Flamingo balance test
2. Seat and reach test
3. Standing broad jump test
4. Handgrip test
5. Sit-ups test
6. Bent arm hang test
7. Twenty meter endurance shuttle run test
8. Wingate anaerobic fitness test
Bone speed of sound test will be performed by a bone sonometer - a non-invasive ultrasound based measurement of bone density.
CD subjects will be evaluated for adherence to GFD via questioning by a pediatric gastroenterologist and a clinical dietitian and by serum tissue transglutaminase immunoglobulin A (IgA) level (or serum deamidated gliadin peptide immunoglobulin G level in IgA deficient subjects). This is part of the normal follow-up of CD patients.

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Celiac disease		Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation
Control		Healthy controls with no chronic condition

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flamingo balance test	Flamingo balance test recorded in times in 60sec (n).	6 months
Sit and reach test	Sit and reach test recorded in cm.	6 months
Standing broad jump test	Standing broad jump test recorded in cm.	6 months
Handgrip test	Handgrip test recorded kg.	6 months
Sit-ups test	Sit-ups test is recorded in times in 30sec (n).	6 months
Bent arm hang test	Bent arm hang test recorded in sec.	6 months
Twenty meter endurance shuttle run test	Twenty meter endurance shuttle run test recorded in times (n).	6 months

Secondary Outcomes

Measure	Description	Time Frame
Weight	Weight in kilograms. Measured with an electronic scale (model 500KL, Health o meter, McCook, IL, USA). Range 0-220kg, rounded to the nearest 0.1kg.	6 months
Height	Height in centimeters. Measured with a wall-mounted stadiometer (model 240, Seca, Hamburg, Germany). Range 0-240cm, rounded to the nearest 0.1cm.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 4-18y visiting the pediatric gastroenterology clinic
Signing a consent form

Exclusion Criteria:

Family history of cardiovascular diseases or sudden death before age 50y
Chronic condition limiting the ability to perform the physical fitness tests (e.g. juvenile idiopathic arthritis)
Failure to complete the measurements and evaluations by 2 months from the date of the visit at the clinic

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

The investigators will enroll 50 newly diagnosed CD subjects. The diagnosis will be in accordance with the European Society for Gastroenterology Hepatology and Nutrition guidelines for the diagnosis of CD from 2012. The investigators will also enroll 50 control subjects. The control subjects are children visiting the pediatric gastroenterology clinic. Before enrollment the investigators will rule out chronic conditions involving the gastrointestinal tract including CD.

All subjects will be enrolled after providing an informed consent and signing the consent form.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eyal Zifman, MD	Meur Medical Center, Kfar-Saba, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba		4464402	Israel