Celiac Disease in AdolescentsNCT05474976
Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease
An observational study of Celiac Disease in Adolescents and Gluten-Free Diet in the Covid-19 Process, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Celiac Disease in Adolescents, Gluten-Free Diet in the Covid-19 Process
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population of this cross-sectional study of adolescents diagnosed with celiac disease in the 10-19 age group, registered to an association. Study sample of 85 participants who met the inclusion criteria and agreed to participate in the study.
Who may be able to join
- Being in the 10-19 age group,
- Being diagnosed with celiac disease according to the revised ESPGHAN criteria,
- Following a gluten-free diet for at least 6 months before the COVID-19 lockdown,
- Consenting to participate in the study by the adolescents and their parents.
Who cannot join
- -Having any cognitive or mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease During the Covid-19 Pandemic
Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. The aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the Covid-19 pandemic and identify the associated factors.
The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. Research data were collected by online questionnaires (Google Forms) between January and April 2022. Sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the COVID-19 pandemic were compared.
- Keywords
- Adolescence, Celiac Disease, gluten free diet
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescents with celiac disease adherence to their diet
In this study, dietary compliance of adolescents with celiac disease was examined using the Gluten-Free Diet Compliance Form.
Measured: 4 month
Secondary outcomes (1)
The effects of the pandemic on the gluten-free diet
The Factors Affecting Gluten-Free Diet Compliance form was used to determine the factors affecting adolescents' adherence to a gluten-free diet during the Covid-19 pandemic period.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in AdolescentsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Irem Aydin, Uludag University
- Investigators
- Ayla İrem Aydın, Phd, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474976
- Sponsor's protocol ID
- 517517518
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared if there is a request for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT05474976
- Acronym / sponsor ID
- 517517518
- Keywords
- Adolescence, Celiac Disease, gluten free diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 26 Jul 2022 (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.
Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. The aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the Covid-19 pandemic and identify the associated factors.
The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. Research data were collected by online questionnaires (Google Forms) between January and April 2022. Sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the COVID-19 pandemic were compared.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population of this cross-sectional study of adolescents diagnosed with celiac disease in the 10-19 age group, registered to an association. Study sample of 85 participants who met the inclusion criteria and agreed to participate in the study.
Key inclusion criteria (4 listed)
- Being in the 10-19 age group,
- Being diagnosed with celiac disease according to the revised ESPGHAN criteria,
- Following a gluten-free diet for at least 6 months before the COVID-19 lockdown,
- Consenting to participate in the study by the adolescents and their parents.
Key exclusion criteria (1 listed)
- -Having any cognitive or mental disorders.
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
Adolescents with celiac disease adherence to their diet
Time frame: 4 month
In this study, dietary compliance of adolescents with celiac disease was examined using the Gluten-Free Diet Compliance Form.
1 secondary outcome
The effects of the pandemic on the gluten-free diet
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No. It can be shared if there is a request for sharing.
Related trials for Celiac Disease in Adolescents
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Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Recruiting
Metaboic Syndrome and Fatty Liver in Celiac Disease Females: Reponse to Exercise in Adolescents
Celiac Disease, Metabolic Syndrome
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Recruiting
Nutrition and Physical Activity Education in Children With Celiac Disease
Celiac Disease, Celiac Disease in Children
Recruiting
Screening for Disorders of Lipid Metabolism and Familial Hyperlipidemia in Children and Adolescents With Increased Cardiovascular Risk Due to Chronic Diseases Such as Congenital Heart Disease, Chronic Inflammatory Bowel Disease, Celiac Disease and Rheumatic Disorders
Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors
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.
Ayla İrem Aydın, Phd principal investigator
Uludag University
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 Adolescents and Gluten-Free Diet in the Covid-19 Process, run by Uludag University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jul 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adolescents with celiac disease adherence to their diet (time frame: 4 month). 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 Jul 2022.