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Quality of Life and Long-term Outcome of Adequately Treated Congenital Hypothyroidism

NCT06864039 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-07

No results posted yet for this study

Summary

The primary objective of this observational study is the evaluation of the quality of life and long-term outccome of young-adult patients with congenital hypothyroidism diagnosed by neonatal screening receiving replacement treatment with levothyroxine.

The secondary objective is to relate the results to the form of hypothyroidism, the initial dose of L-T4, treatment adherence and genetics

Conditions

  • Congenital Hypothyroidism

Interventions

DIAGNOSTIC_TEST

SF36 test

Assessment of quality of life by administering the SF36 test

DIAGNOSTIC_TEST

WAIS IV test

Assessment of cognitive abilities by administering the WAIS IV test

DIAGNOSTIC_TEST

SCL-90 psychopathological screening questionnaire

Assessment of any psychopathological conditions by means of the SCL-90 psychopathological screening questionnaire

DIAGNOSTIC_TEST

CBCL questionnaire

For patients up to 18 years of age: CBCL questionnaire to be administered to parents to describe the patient's behavior

DIAGNOSTIC_TEST

bioimpedance analysis

Assessment of body composition by performing bioimpedance analysis

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864039 on ClinicalTrials.gov