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

Phase 4

Completed

• Conditions: Quality of Life; Depression
• Interventions: Drug: Triiodothyronine

• Registration Number: NCT00531713
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

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

Detailed Description

double blind randomized cross-over study.

Study Timeline

• Study Start: 2003-04
• Study Completion: 2007-03
• Status Verified: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Last Update Submitted: 2007-09-18
• Study First Posted: 2007-09-19
• Last Update Posted: 2007-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

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

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Exclusion Criteria

• <18 år
• >75 år
• pregnant women
• Thyroid cancer
• T3 treatment
• Post-partum thyroiditis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Triiodothyronine	20 microgram of T3 is given and 50 microgram of T4 is withdrawn

Primary Outcome Measures

Name	Time	Method
Selv-rating scales: SF-36, SCL -90-R, BDI	3 month treating

Secondary Outcome Measures

Name	Time	Method
BMI, bioimpedance	3 month treament

Trial Locations

Locations (1)

Dept of endocrinology , Herlev Hospital; 🇩🇰 Herlev, Denmark