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

NCT ID: NCT00531713

Last Updated: 2007-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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double blind randomized cross-over study.

Conditions

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Quality of Life Depression

Keywords

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hypothyroidism, quality og life, depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Usual T4 dose is given

Group Type NO_INTERVENTION

No interventions assigned to this group

2

20 microgram of T3 is given and 50 microgram of T4 is withdrawn

Group Type ACTIVE_COMPARATOR

Triiodothyronine

Intervention Type DRUG

50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Interventions

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Triiodothyronine

50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Principal Investigators

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Birte Nygaard

Role: PRINCIPAL_INVESTIGATOR

Herlev Trials

Locations

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Dept of endocrinology , Herlev Hospital

Herlev, Herlev, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA 02022ms

Identifier Type: -

Identifier Source: secondary_id

T4-T3 hypothyreose

Identifier Type: -

Identifier Source: org_study_id