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

This study has been completed.

First Received: September 18, 2007 No Changes Posted

Sponsor:	Copenhagen University Hospital at Herlev
Information provided by:	Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:	NCT00531713

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Depression

Drug Information available for: Liothyronine sodium Triiodothyronine

U.S. FDA Resources

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
1: No Intervention Usual T4 dose is given
2: Active Comparator 20 microgram of T3 is given and 50 microgram of T4 is withdrawn	Drug: Triiodothyronine 50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3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

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

Study ID Numbers:	T4-T3 hypothyreose, KA 02022ms
Study First Received:	September 18, 2007
Last Updated:	September 18, 2007
ClinicalTrials.gov Identifier:	NCT00531713 History of Changes
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
Mental Disorders
Mood Disorders
Endocrine System Diseases

Hypothyroidism
Depressive Disorder
Thyroid Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 08, 2010