Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism

This study has been completed.
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00531713
First received: September 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy


Condition Intervention Phase
Quality of Life
Depression
Drug: Triiodothyronine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Selv-rating scales: SF-36, SCL -90-R, BDI [ Time Frame: 3 month treating ]

Secondary Outcome Measures:
  • BMI, bioimpedance [ Time Frame: 3 month treament ]

Enrollment: 59
Study Start Date: April 2003
Study Completion Date: March 2007
Arms Assigned Interventions
No Intervention: 1
Usual T4 dose is given
Active Comparator: 2
20 microgram of T3 is given and 50 microgram of T4 is withdrawn
Drug: Triiodothyronine
50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Detailed Description:

double blind randomized cross-over study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.

Exclusion Criteria:

  • <18 år
  • >75 år
  • pregnant women
  • Thyroid cancer
  • T3 treatment
  • Post-partum thyroiditis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531713

Locations
Denmark
Dept of endocrinology , Herlev Hospital
Herlev, Denmark, dk-3650
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Birte Nygaard Herlev Trials
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00531713     History of Changes
Other Study ID Numbers: T4-T3 hypothyreose, KA 02022ms
Study First Received: September 18, 2007
Last Updated: September 18, 2007
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Copenhagen University Hospital at Herlev:
hypothyroidism, quality og life, depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hypothyroidism
Behavioral Symptoms
Mood Disorders
Mental Disorders
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014