Study Stopped
Inability to recruit and perform study visits due to COVID19 pandemic
Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
1 other identifier
observational
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2022
CompletedAugust 26, 2022
August 1, 2022
2.6 years
June 24, 2019
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 (5)
Weight
6 months
Height
6 months
Body mass index
6 months
Total body fat
6 months
Bone speed of sound
6 months
Study Arms (2)
Celiac disease
Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation
Control
Healthy controls with no chronic condition
Eligibility Criteria
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.
You may qualify if:
- Children aged 4-18y visiting the pediatric gastroenterology clinic
- Signing a consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, 4464402, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Eyal Zifman, MD
Meur Medical Center, Kfar-Saba, Israel
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pediatric Gastroenterology Service
Study Record Dates
First Submitted
June 24, 2019
First Posted
July 9, 2019
Study Start
August 13, 2019
Primary Completion
April 5, 2022
Study Completion
April 5, 2022
Last Updated
August 26, 2022
Record last verified: 2022-08