Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism

Congenital Hypothyroidism Clinical Trial

— CHRO1  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497575
• Other study ID #: no. 2002C23037
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: July 5, 2007
• Start date: October 1999
• Est. completion date: September 2006

Study information

• Verified date: July 2007
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2006
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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 Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Congenital Hypothyroidism
• Follow-Up
• Hypothyroidism
• L-Thyroxine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University