Celiac Disease in ChildrenNCT04012736
Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
An observational study of Celiac Disease in Children, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Aug 2019to 5 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Children aged 4-18y visiting the pediatric gastroenterology clinic
- Signing a consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Flamingo balance test
- Seat and reach test
- Standing broad jump test
- Handgrip test
- Sit-ups test
- Bent arm hang test
- Twenty meter endurance shuttle run test
- 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.
- Conditions
- Celiac Disease in Children
- Keywords
- gluten free diet, fitness, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Celiac disease | Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation | |
| Control | Healthy controls with no chronic condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flamingo balance test
Flamingo balance test recorded in times in 60sec (n).
Measured: 6 months
Sit and reach test
Sit and reach test recorded in cm.
Measured: 6 months
Standing broad jump test
Standing broad jump test recorded in cm.
Measured: 6 months
Handgrip test
Handgrip test recorded kg.
Measured: 6 months
Sit-ups test
Sit-ups test is recorded in times in 30sec (n).
Measured: 6 months
Bent arm hang test
Bent arm hang test recorded in sec.
Measured: 6 months
Twenty meter endurance shuttle run test
Twenty meter endurance shuttle run test recorded in times (n).
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 6 months
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 6 months
Total body fat
Total body fat in percents. Measured with a body composition scale (model MC-780U, Tanita, Arlington Heights, IL, USA).
Measured: 6 months
Bone speed of sound
Bone speed of sound in m/s. Measured with a bone sonometer (Sunlight Omnisense, Somerset, NJ, USA).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start13 Aug 2019
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Why it stopped: Inability to recruit and perform study visits due to COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eyal zifman, Meir Medical Center
- Investigators
- Eyal Zifman, MD, Principal investigator, Meur Medical Center, Kfar-Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012736
- Sponsor's protocol ID
- MMC059-19CTIL
- Status last verified
- Aug 2022
- First submitted
- 24 Jun 2019
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet
- ClinicalTrials.gov ID
- NCT04012736
- Acronym / sponsor ID
- MMC059-19CTIL
- Conditions
- Celiac Disease in Children
- Keywords
- gluten free diet, fitness, pediatric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to recruit and perform study visits due to COVID19 pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Flamingo balance test
- Seat and reach test
- Standing broad jump test
- Handgrip test
- Sit-ups test
- Bent arm hang test
- Twenty meter endurance shuttle run test
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac disease | – | –Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation |
| Control | – | –Healthy controls with no chronic condition |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Children aged 4-18y visiting the pediatric gastroenterology clinic
- Signing a consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flamingo balance test
Time frame: 6 months
Flamingo balance test recorded in times in 60sec (n).
Sit and reach test
Time frame: 6 months
Sit and reach test recorded in cm.
Standing broad jump test
Time frame: 6 months
Standing broad jump test recorded in cm.
Handgrip test
Time frame: 6 months
Handgrip test recorded kg.
Sit-ups test
Time frame: 6 months
Sit-ups test is recorded in times in 30sec (n).
Bent arm hang test
Time frame: 6 months
Bent arm hang test recorded in sec.
Twenty meter endurance shuttle run test
Time frame: 6 months
Twenty meter endurance shuttle run test recorded in times (n).
5 secondary outcomes
Weight
Time frame: 6 months
Height
Time frame: 6 months
Body mass index
Time frame: 6 months
Total body fat
Time frame: 6 months
Bone speed of sound
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Inability to recruit and perform study visits due to COVID19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
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Celiac Disease in Childhood-Adulthood Transition
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Zifman, MD principal investigator
Meur Medical Center, Kfar-Saba, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit and perform study visits due to COVID19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flamingo balance test (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.