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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 5, 2007 | ||||
| Last Updated Date | July 5, 2007 | ||||
| Start Date ICMJE | October 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism | ||||
| Official Title ICMJE | |||||
| Brief Summary | 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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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening, Longitudinal, Defined Population, Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 5 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00497575 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | no. 2002C23037 | ||||
| Study Sponsor ICMJE | Zhejiang University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Zhejiang University | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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