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Completed

NCT Number: NCT00497575

Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism

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.

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Key information

About this study

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.

Who can participate

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

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.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Acronym: CHRO1

Important dates

Study start
1999
Study completion
2006
First posted
Jul 6, 2007
Registry last updated
Jul 6, 2007

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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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