Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone

Not Applicable

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: thyroxine; Drug: thyroxine and triiodothyronine

• Registration Number: NCT00715572
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

The objective of this study was to analyze the features of monotherapy with L-T4 in comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.

Detailed Description

We conducted a randomized controlled study with a crossover design in 36 premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones. All patients were divided into two groups: patients from Group A (n=20) were randomized to L-T4 in dose of 1,6 μg per kg, followed by combined L-T4 and L-T3; and 16 women from Group B received the combination of L-T4+L-T3 (the dose of L-T4 was reduced by 25 μg and replaced with 12,5 μg of L-T3), followed by monotherapy with L-T4. The treatment periods lasted for 6 months. Patients were examined at baseline and at the end of each treatment period.Blood samples were obtained to measure serum TSH, free T4, free T3, lipid profile, osteocalcin. Urine samples were collected to measure urinary deoxypyridinoline / creatinine ratio. 24-hour ECG-monitoring, osteodensitometry and psychological testing were also performed at baseline and at the end of each treatment period.

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2004-02
• Study Completion: 2004-05
• Status Verified: 2008-07
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-14
• Last Update Submitted: 2008-07-14
• Study First Posted: 2008-07-15
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones

Exclusion Criteria

• Peri- and postmenopause
• Pregnancy
• Major comorbidity
• Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	thyroxine	-
B	thyroxine and triiodothyronine	-

Primary Outcome Measures

Name	Time	Method
biochemical parameters	the end of each period of treatment