Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism
Information source: Zhejiang University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Hypothyroidism; L-Thyroxine; Follow-Up
Phase: N/A
Status: Completed
Sponsored by: Zhejiang University Official(s) and/or principal investigator(s):
zhengyan Zhao, doctor, Study Director, Affiliation: Pediatric Society of the Chinese Medical Association
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.
Clinical Details
Study design: Screening, Longitudinal, Defined Population, Prospective Study
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
Minimum age: N/A.
Maximum age: 5 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: October 1999
Ending date: September 2006
Last updated: July 5, 2007
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