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

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT00715572
Collaborator
(none)
36
Enrollment
2
Arms
26
Duration (Months)

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
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
Study Start Date :
Mar 1, 2002
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
May 1, 2004

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: A

Drug: thyroxine
monotherapy with thyroxine

Active Comparator: B

Drug: thyroxine and triiodothyronine
combination with thyroxine and triiodothyronine

Outcome Measures

Primary Outcome Measures

  1. biochemical parameters [the end of each period of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 48 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Valentin V Fadeyev, Moscow Medical Academy, Department of Endocrinology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00715572
Other Study ID Numbers:
  • T3T42008
  • T3T42005
First Posted:
Jul 15, 2008
Last Update Posted:
Jul 15, 2008
Last Verified:
Jul 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2008