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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism

Conditions
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Hypothyroidism

Intervention / Treatment
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* Drug: thyroxine
* Drug: thyroxine and triiodothyronine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: thyroxine<br>* monotherapy with thyroxine<br>|
| Active Comparator: B<br> | Drug: thyroxine and triiodothyronine<br>* combination with thyroxine and triiodothyronine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical parameters |  | the end of each period of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothyroidism, treatment, thyroxine, triiodothyronine