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

Primary Purpose

Quality of Life, Depression

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Triiodothyronine
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring hypothyroidism, quality og life, depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of endocrinology , Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Usual T4 dose is given

20 microgram of T3 is given and 50 microgram of T4 is withdrawn

Outcomes

Primary Outcome Measures

Selv-rating scales: SF-36, SCL -90-R, BDI

Secondary Outcome Measures

BMI, bioimpedance

Full Information

First Posted
September 18, 2007
Last Updated
September 18, 2007
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT00531713
Brief Title
Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
Acronym
T4-T3
Official Title
Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy
Detailed Description
double blind randomized cross-over study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Depression
Keywords
hypothyroidism, quality og life, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Usual T4 dose is given
Arm Title
2
Arm Type
Active Comparator
Arm Description
20 microgram of T3 is given and 50 microgram of T4 is withdrawn
Intervention Type
Drug
Intervention Name(s)
Triiodothyronine
Intervention Description
50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3
Primary Outcome Measure Information:
Title
Selv-rating scales: SF-36, SCL -90-R, BDI
Time Frame
3 month treating
Secondary Outcome Measure Information:
Title
BMI, bioimpedance
Time Frame
3 month treament

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birte Nygaard
Organizational Affiliation
Herlev Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of endocrinology , Herlev Hospital
City
Herlev
ZIP/Postal Code
dk-3650
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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