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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715572
First Posted: July 15, 2008
Last Update Posted: July 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
I.M. Sechenov First Moscow State Medical University
  Purpose
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.

Condition Intervention
Hypothyroidism Drug: thyroxine Drug: thyroxine and triiodothyronine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism

Resource links provided by NLM:


Further study details as provided by I.M. Sechenov First Moscow State Medical University:

Primary Outcome Measures:
  • biochemical parameters [ Time Frame: the end of each period of treatment ]

Enrollment: 36
Study Start Date: March 2002
Study Completion Date: May 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: thyroxine
monotherapy with thyroxine
Active Comparator: B Drug: thyroxine and triiodothyronine
combination with thyroxine and triiodothyronine

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715572


Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
Principal Investigator: Valentin V Fadeyev Moscow Medical Academy, Department of Endocrinology
  More Information

Responsible Party: The I.M. Sechenov Moscow Medical Academy, Department of Endocrinology
ClinicalTrials.gov Identifier: NCT00715572     History of Changes
Other Study ID Numbers: T3T42008
T3T42005
First Submitted: July 11, 2008
First Posted: July 15, 2008
Last Update Posted: July 15, 2008
Last Verified: July 2008

Keywords provided by I.M. Sechenov First Moscow State Medical University:
hypothyroidism, treatment, thyroxine, triiodothyronine

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases