An observational study in Celiac Disease in Children, sponsored by Meir Medical Center. Terminated at 1 site in Israel. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Meir Medical Center · Observational
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.
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:
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 3 is below the median of 160 across 126 observational studies indexed under Celiac Disease.
Browse Celiac Disease studies →Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation
Healthy controls with no chronic condition
Flamingo balance test
Flamingo balance test recorded in times in 60sec (n).
Time frame: 6 months
Sit and reach test
Sit and reach test recorded in cm.
Time frame: 6 months
Standing broad jump test
Standing broad jump test recorded in cm.
Time frame: 6 months
Handgrip test
Handgrip test recorded kg.
Time frame: 6 months
Sit-ups test
Sit-ups test is recorded in times in 30sec (n).
Time frame: 6 months
Bent arm hang test
Bent arm hang test recorded in sec.
Time frame: 6 months
Twenty meter endurance shuttle run test
Twenty meter endurance shuttle run test recorded in times (n).
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
Body mass index
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 6 months
Total body fat
Total body fat in percents. Measured with a body composition scale (model MC-780U, Tanita, Arlington Heights, IL, USA).
Time frame: 6 months
Bone speed of sound
Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).
Time frame: 6 months
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Meir Medical Center