Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism - Full Text View

Sponsored by:	Zhejiang University
Information provided by:	Zhejiang University
ClinicalTrials.gov Identifier:	NCT00497575

Purpose

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.

Condition
Congenital Hypothyroidism L-Thyroxine Follow-Up

Genetics Home Reference related topics: congenital hypothyroidism pseudoachondroplasia

Drug Information available for: Levothyroxine Sodium Thyroxine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study

Further study details as provided by Zhejiang University:

Study Start Date:	October 1999
Study Completion Date:	September 2006

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

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497575

Sponsors and Collaborators

Zhejiang University

Investigators

Study Director:

zhengyan Zhao, doctor

Pediatric Society of the Chinese Medical Association

More Information

Study ID Numbers:	no. 2002C23037
Study First Received:	July 5, 2007
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00497575
Health Authority:	China: Ministry of Health

Keywords provided by Zhejiang University:

Congenital Hypothyroidism
diagnosis
L-thyroxine
newborn screening

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Cretinism
Endocrine System Diseases
Bone Diseases
Congenital hypothyroidism
Musculoskeletal Diseases

Genetic Diseases, Inborn
Congenital Hypothyroidism
Bone Diseases, Developmental
Hypothyroidism
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on January 16, 2009