Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
Primary Purpose
Hypothyroidism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroxine
thyroxine and triiodothyronine
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism focused on measuring hypothyroidism, treatment, thyroxine, triiodothyronine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
biochemical parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT00715572
First Posted
July 11, 2008
Last Updated
July 14, 2008
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00715572
Brief Title
Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
Official Title
Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone in the Treatment of Primary Hypothyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
hypothyroidism, treatment, thyroxine, triiodothyronine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
thyroxine
Intervention Description
monotherapy with thyroxine
Intervention Type
Drug
Intervention Name(s)
thyroxine and triiodothyronine
Intervention Description
combination with thyroxine and triiodothyronine
Primary Outcome Measure Information:
Title
biochemical parameters
Time Frame
the end of each period of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentin V Fadeyev
Organizational Affiliation
Moscow Medical Academy, Department of Endocrinology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
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