Entities and Variables Related to Catch-up Growth

NCT06364735 | Recruiting

• 1 other identifier: Entità e variabili
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease in Children

Outcome Measures

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).

  6 and 24 month

Secondary Outcomes (1)

• Calculate the degree of catch-up growth

  6 and 24 month

Other Outcomes (2)

• Exploratory objectives 1

  6 and 24 month

• Exploratory objectives 2

  6 and 24 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Childhood celiac disease patients on a gluten-free diet

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

ASST Fatebenefratelli Sacco

Milan, 2015, Italy

RECRUITING

Central Study Contacts

Elena Groppali, MD

CONTACT

00390263631; elena.groppali@asst-fbf-sacco.it

Elena Groppali, MD

CONTACT

00390263635331; elena.groppali@asst-fbf-sacco.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)