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

This study has been completed.
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00497575
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

July 5, 2007
July 5, 2007
October 1999
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Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism
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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.

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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  • Congenital Hypothyroidism
  • L-Thyroxine
  • Follow-Up
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2006
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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.
Both
up to 5 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00497575
no. 2002C23037
Yes
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Zhejiang University
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Study Director: zhengyan Zhao, doctor Pediatric Society of the Chinese Medical Association
Zhejiang University
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP