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Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism (CHRO1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497575
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zhejiang University
  Purpose
Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with subclinical hypothyroidism ,and evaluate the curative effect.

Condition
Congenital Hypothyroidism L-Thyroxine Follow-Up

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Study Start Date: October 1999
Study Completion Date: September 2006
Detailed Description:
Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with hyperthyrotropinemia,and evaluate the curative effect.All live-born neonates in province took part in the screening program from October, 1999 to September ,2006. Laboratory tests are performed as a time resolved fluoro-immunoassay (TRFIA). TSH is measured with a cut-off > 9 mU/L. The diagnostic standard for subclinical hypothyroidism was: TSH ≥ 20 mU/L, T3 and T4 normal or low-normal ,or TSH > 5.6 mU/L and < 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.L-Thyroxine was administered for substitution therapy. After 2 years therapy,allround evaluation was performed. Compare the correlation to effects with different level of TSH、starting time of therapy and environment. Compare the effects between subclinical、temporary and permanent hypothyroidism.
  Eligibility

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows:

    • Hypothyroidism - TSH > 40 mU/L and T3 and T4 below the reference range or TSH > 40 mU/L, T3 normal and T4 below the reference range [2]
    • Subclinical hypothyroidism - TSH ≥ 20 mU/L, T3 and T4 normal or low-normal or TSH > 5.6 mU/L and < 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497575


Sponsors and Collaborators
Zhejiang University
Investigators
Study Director: zhengyan Zhao, doctor Pediatric Society of the Chinese Medical Association
  More Information

ClinicalTrials.gov Identifier: NCT00497575     History of Changes
Other Study ID Numbers: no. 2002C23037
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
Last Verified: July 2007

Keywords provided by Zhejiang University:
Congenital Hypothyroidism
diagnosis
L-thyroxine
newborn screening

Additional relevant MeSH terms:
Hypothyroidism
Congenital Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Genetic Diseases, Inborn