Entities and Variables Related to Catch-up Growth

Recruiting

• Conditions: Celiac Disease in Children

• Registration Number: NCT06364735
• Lead Sponsor: ASST Fatebenefratelli Sacco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the catch-up growth degree.	6 and 24 month	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).

Secondary Outcome Measures

Name	Time	Method
Calculate the degree of catch-up growth	6 and 24 month	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.

Trial Locations

Locations (1)

ASST Fatebenefratelli Sacco; 🇮🇹 Milan, Italy