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

NCT ID: NCT00715572

Last Updated: 2008-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2004-05-31

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

thyroxine

Intervention Type: DRUG

monotherapy with thyroxine

B

Group Type: ACTIVE_COMPARATOR

thyroxine and triiodothyronine

Intervention Type: DRUG

combination with thyroxine and triiodothyronine

Interventions

thyroxine

monotherapy with thyroxine

Intervention Type: DRUG

thyroxine and triiodothyronine

combination with thyroxine and triiodothyronine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology

Principal Investigators

Valentin V Fadeyev

Role: PRINCIPAL_INVESTIGATOR

Moscow Medical Academy, Department of Endocrinology

Other Identifiers

T3T42005

Identifier Type: -

Identifier Source: secondary_id

T3T42008

Identifier Type: -

Identifier Source: org_study_id