NCT00531713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_4 quality-of-life

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4 quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
Last Updated

September 19, 2007

Status Verified

September 1, 2007

First QC Date

September 18, 2007

Last Update Submit

September 18, 2007

Conditions

Quality of LifeDepression

Keywords

hypothyroidism, quality og life, depression

Outcome Measures

Primary Outcomes (1)

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

    3 month treating

Secondary Outcomes (1)

  • BMI, bioimpedance

    3 month treament

Study Arms (2)

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20 microgram of T3 is given and 50 microgram of T4 is withdrawn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

Interventions

TriiodothyronineDRUG

50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<18 år
  • \>75 år
  • pregnant women
  • Thyroid cancer
  • T3 treatment
  • Post-partum thyroiditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of endocrinology , Herlev Hospital

Herlev, Herlev, dk-3650, Denmark

Location

MeSH Terms

Conditions

DepressionHypothyroidism

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Birte Nygaard

    Herlev Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 19, 2007

Study Start

April 1, 2003

Study Completion

March 1, 2007

Last Updated

September 19, 2007

Record last verified: 2007-09

Locations

DK(1)