Entities and Variables Related to Catch-up Growth
ConditionCeliac Disease in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorASST Fatebenefratelli Sacco
About this trial
A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
celiac disease diagnosis established at the V. Buzzi Children's Hospital in Milan between January 2010 and December 2020, excluding the extremes, in accordance with the ESPGHAN 2012 or 2020 recommendations.
Disqualifiers
patients with unclear or non-specific duodenal histological alterations (e.g., atrophy with unavailable or negative specific antibodies for celiac disease);
patients with additional chronic illnesses;
absence of the data required for the study;
patients with IgA deficiency, defined as IgA <20 mg/dl in children <3 years old or with levels that are below normal for their age.
Trial population
Childhood celiac disease patients on a gluten-free diet
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measure the catch-up growth degree.
Changes in the auxological weight variable in pediatric patients with celiac disease were measured 6 months and 24 months after they started a gluten-free diet. The change was expressed as an average daily weight increase and compared with the average increase expected for sex and age in a healthy population extrapolated from validated curves (Cacciari).
Time frame
6 and 24 monthSecondary outcomes
1
Calculate the degree of catch-up growth
Variation in the auxological variable of height in pediatric patients with celiac disease, measured as variation in the standard deviation of this variable compared to reference values for age and sex extrapolated from validated curves (Cacciari curves), at six and twenty-four months after the start of the gluten-free diet.
Time frame
6 and 24 monthOther outcomes
1
Exploratory objectives 1
Identify the correlation between the degree of catch-up growth and the persistence of the symptoms, MC-related antibody positivity and the level of diet adherence at the 6- and 24-month follow-up
Time frame
6 and 24 month2
Exploratory objectives 2
Define the degree of celiac disease's clinical, endoscopic, histological, and serological severity at the time the sample was diagnosed, and then correlate it to the degree of catch-up growth that occurred 6 and 24 months after the gluten-free diet was started
Time frame
6 and 24 monthSponsors and contacts
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Source ClinicalTrials.gov