- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00497575
Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism (CHRO1)
July 5, 2007 updated by: Zhejiang University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: zhengyan Zhao, doctor, Pediatric Society of the Chinese Medical Association
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1999
Study Completion (ACTUAL)
September 1, 2006
Study Registration Dates
First Submitted
July 5, 2007
First Submitted That Met QC Criteria
July 5, 2007
First Posted (ESTIMATE)
July 6, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 6, 2007
Last Update Submitted That Met QC Criteria
July 5, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- no. 2002C23037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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