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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 4 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Children aged 4-18y visiting the pediatric gastroenterology clinic. 2. Signing a consent form.

Exclusion Criteria:

1. Family history of cardiovascular diseases or sudden death before age 50y. 2. Chronic condition limiting the ability to perform the physical fitness tests (e.g. juvenile idiopathic arthritis) 3. Failure to complete the measurements and evaluations by 2 months from the date of the visit at the clinic

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04012736
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Meir Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eyal Zifman, MD
Principal Investigator Affiliation Meur Medical Center, Kfar-Saba, Israel
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Celiac Disease in Children
Additional Details

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: 1. 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. 2. A Godin leisure-time exercise questionnaire

  • (7) will be filled by the subjects and their parents.
3. 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. 4. Bone speed of sound test will be performed by a bone sonometer
  • - a non-invasive ultrasound based measurement of bone density.
5. 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.

Arms & Interventions

Arms

: Celiac disease

Celiac disease subjects enrolled after diagnosis and before gluten free diet initiation

: Control

Healthy controls with no chronic condition

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 4464402

Site Contact

Eyal Zifman, MD

eyalzi@clalit.org.il

+972545740004

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