NCT04457518

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
824

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

June 26, 2020

Last Update Submit

February 25, 2021

Conditions

Keywords

İnflammatory bowel diseasechildrennutritional status

Outcome Measures

Primary Outcomes (1)

  • nutritional profiles of children with IBD

    evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters

    Day 1 of diagnosis

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Secondary and Tertiary Care Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Zarife Kuloglu, M.D.

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD.

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 7, 2020

Study Start

June 25, 2020

Primary Completion

September 30, 2020

Study Completion

October 30, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations