Inflammatory Bowel DiseasesNCT04457518
Nutritional Status in Children With IBD
An observational study of Inflammatory Bowel Diseases and Child, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Malnutrition and growth retardation are major extraintestinal presentations of inflammatory bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's disease. We aimed to evaluate nutritional status of children with IBD at the time of diagnosis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Child
- How many people
- 824 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2020to 30 Oct 2020
- How long will I take part?
- 1 Day
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Secondary and Tertiary Care Hospital
Who may be able to join
- Age: ≤ 18 years
- Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings
- No other chronical diseases known affect nutritional status
- No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Who cannot join
- Age: >18 years old
- Another chronical disease known affect nutritional status
- Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status in Children With Inflammatory Bowel Disease
Malnutrition and growth retardation are major extraintestinal presentations of inflammatory bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's disease. We aimed to evaluate nutritional status of children with IBD at the time of diagnosis.
Read the detailed description
Data for this study will be derived from the web-based National Registry for Pediatric IBD. The children (age: ≤ 18 years) who diagnosed with IBD according to international criteria will be eligible for enrollment. Data on demographic, clinical and laboratory characteristics at the time of diagnosis were extracted from the registry. All cases in the registry will be screened for eligibility criteria by principal investigator (senior gastroenterologist). The patients with other chronic disease known affect nutritional status will be excluded. The cases who had the missing major outcome variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis will be excluded from the analysis, if they had all of these outcome variables, they were included.
The nutritional status of participants will be evaluated based on anthropometric parameters. The weight status will be assessed by weight-for-length in children <2 years of age, and BMI-for-age in children 2 years of age and older. Height status will be evaluated by length/height-for-age in all cases. Age-and-sex specific percentile and the corresponding z score for all anthropometric parameters will be calculated in the WHOAnthro for under five years and WHOAnthroplus (WHO, Geneva, Switzerland) for those aged 5-18 years by using WHO standards and references. Z-scores between +2.0 and -2.0 for all parameters will be considered normal. Wasted/thinness and overweight will be defined by weight-for-length/BMI z score < -2.0, and > +2.0, respectively. Stunting (short stature) and tallness will be defined as length/height-for-age z score < -2.0 and > +2.0, respectively. Children will be stratified into two age groups for analysis: < 10 years of age and older. A p value of <0.05 was considered statistically significant.
- Conditions
- Inflammatory Bowel Diseases, Child
- Keywords
- İnflammatory bowel disease, children, nutritional status
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional profiles of children with IBD
evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters
Measured: Day 1 of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start25 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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 only
- Time perspective
- Other
- Enrolment
- 824 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Responsible party
- Principal investigator, Zarife Kuloglu, Ankara University
- Investigators
- Zarife Kuloglu, M.D., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457518
- Sponsor's protocol ID
- 12.10.2011/11-7/2
- Status last verified
- Feb 2021
- First submitted
- 26 Jun 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuloglu Z, Cetin F, Urganci N, Onal Z, Sari S, Yuksekkaya H, Caltepe G, Kutluk G, Dumlupinar E; Turkish Inflammatory Bowel Disease Study Group. Nutritional characteristic of children with inflammatory bowel disease in the nationwide inflammatory bowel disease registry from the Mediterranean region. Eur J Clin Nutr. 2022 Sep;76(9):1289-1296. doi: 10.1038/s41430-022-01094-6. Epub 2022 Feb 16.
PubMed 35173290
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04457518
- Acronym / sponsor ID
- 12.10.2011/11-7/2
- Conditions
- Inflammatory Bowel Diseases, Child
- Keywords
- İnflammatory bowel disease, children, nutritional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 7 Jul 2020 (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.
Malnutrition and growth retardation are major extraintestinal presentations of inflammatory bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's disease. We aimed to evaluate nutritional status of children with IBD at the time of diagnosis.
Detailed description
Data for this study will be derived from the web-based National Registry for Pediatric IBD. The children (age: ≤ 18 years) who diagnosed with IBD according to international criteria will be eligible for enrollment. Data on demographic, clinical and laboratory characteristics at the time of diagnosis were extracted from the registry. All cases in the registry will be screened for eligibility criteria by principal investigator (senior gastroenterologist). The patients with other chronic disease known affect nutritional status will be excluded. The cases who had the missing major outcome variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis will be excluded from the analysis, if they had all of these outcome variables, they were included.
The nutritional status of participants will be evaluated based on anthropometric parameters. The weight status will be assessed by weight-for-length in children <2 years of age, and BMI-for-age in children 2 years of age and older. Height status will be evaluated by length/height-for-age in all cases. Age-and-sex specific percentile and the corresponding z score for all anthropometric parameters will be calculated in the WHOAnthro for under five years and WHOAnthroplus (WHO, Geneva, Switzerland) for those aged 5-18 years by using WHO standards and references. Z-scores between +2.0 and -2.0 for all parameters will be considered normal. Wasted/thinness and overweight will be defined by weight-for-length/BMI z score < -2.0, and > +2.0, respectively. Stunting (short stature) and tallness will be defined as length/height-for-age z score < -2.0 and > +2.0, respectively. Children will be stratified into two age groups for analysis: < 10 years of age and older. A p value of <0.05 was considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Secondary and Tertiary Care Hospital
Key inclusion criteria (4 listed)
- Age: ≤ 18 years
- Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings
- No other chronical diseases known affect nutritional status
- No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Key exclusion criteria (3 listed)
- Age: >18 years old
- Another chronical disease known affect nutritional status
- Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
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
nutritional profiles of children with IBD
Time frame: Day 1 of diagnosis
evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters
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 1 Mar 2021.
- Derived from this study: PubMed 35173290Kuloglu Z, Cetin F, Urganci N, Onal Z, Sari S, Yuksekkaya H, Caltepe G, Kutluk G, Dumlupinar E; Turkish Inflammatory Bowel Disease Study Group. Nutritional characteristic of children with inflammatory bowel disease in the nationwide inflammatory bowel disease registry from the Mediterranean region. Eur J Clin Nutr. 2022 Sep;76(9):1289-1296. doi: 10.1038/s41430-022-01094-6. Epub 2022 Feb 16.
- Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutritionLink provided by the sponsor.
- Nutritional concerns in pediatric inflammatory bowel diseaseLink provided by the sponsor.
- Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHANLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Zarife Kuloglu, M.D. principal investigator
Ankara 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 Inflammatory Bowel Diseases and Child, run by Ankara 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 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: finished, as of the sponsor's last update on 1 Mar 2021. 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?
nutritional profiles of children with IBD (time frame: Day 1 of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04457518, which also lists 1 linked publication.
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 1 Mar 2021.