Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism

Depression Clinical Trial

— T4-T3  

Official title:

Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531713
• Other study ID #: T4-T3 hypothyreose
• Secondary ID: KA 02022ms
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2007
• Last updated: September 18, 2007
• Start date: April 2003
• Est. completion date: March 2007

Study information

• Verified date: September 2007
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

Description:

double blind randomized cross-over study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.

Exclusion Criteria:

• <18 år

• >75 år

• pregnant women

• Thyroid cancer

• T3 treatment

• Post-partum thyroiditis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Hypothyroidism
• Quality of Life

Intervention

Drug:
• Triiodothyronine
50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Locations

Country	Name	City	State
Denmark	Dept of endocrinology , Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selv-rating scales: SF-36, SCL -90-R, BDI		3 month treating
Secondary	BMI, bioimpedance		3 month treament