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NCT Number: NCT06364735

Entities and Variables Related to Catch-up Growth

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.

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Key information

Conditions

Celiac Disease in Children

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Fatebenefratelli Sacco

Milan, 2015, Italy

Location status: Recruiting

Location contact

Elena MD Groppali

CONTACT

[email protected]

Elena MD Groppali

CONTACT

Elena MD Groppali

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measure the catch-up growth degree.

    Time frame: 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 outcomes

  1. Calculate the degree of catch-up growth

    Time frame: 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.

Other outcomes

  1. Exploratory objectives 1

    Time frame: 6 and 24 month

    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

  2. Exploratory objectives 2

    Time frame: 6 and 24 month

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Groppali, MD

CONTACT

[email protected]

00390263631

Elena Groppali, MD

CONTACT

[email protected]

00390263635331

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Official study title

Entities and Variables Related to Catch-up Growth in Pediatric Patients With Celiac Disease (CD) on a Gluten-free Diet (GFD)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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