Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

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

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-14

Study Completion Date

2022-06-30

Brief Summary

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The aim of the study is to evaluate the peripheral tissue response to the combined administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with residual thyroid function virtually absent (thyroidectomized). Cases will be treated with LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and placebo. Treatment duration: 24 weeks.

The primary endpoint will be the peripheral effect of thyroid hormones. The secondary endpoints are bone and metabolic modifications, and changes in quality of life. Moreover any changes of outcomes related to polymorphisms of genes involved in thyroid hormones metabolism will be evaluated.

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Detailed Description

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Conditions

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Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CASES

treatment with levothyroxine and liothyronine

Group Type EXPERIMENTAL

Liothyronine

Intervention Type DRUG

Cases will take liothyronine drops in the morning and two hours after dinner

Levothyroxin

Intervention Type DRUG

Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)

CONTROLS

treatment with levothyroxine and placebo

Group Type ACTIVE_COMPARATOR

Levothyroxin

Intervention Type DRUG

Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)

Placebos

Intervention Type DRUG

Controls will take placebo two hours after dinner

Interventions

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Liothyronine

Cases will take liothyronine drops in the morning and two hours after dinner

Intervention Type DRUG

Levothyroxin

Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)

Intervention Type DRUG

Placebos

Controls will take placebo two hours after dinner

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* older than 18 years
* capable of consent
* able to fill in a questionnaire in italian
* thyroidectomized
* serum thyroglobulin levels below 0.2 ng/ml and antibodies anti-thyroglobulin undetectable (below normal range)
* well treated taking stable doses of levothyroxine in tablets, in the previous 3 months

Exclusion Criteria

* TSH suppressive therapy
* pregnancy
* cardiac arrhythmias
* severe liver, kidney or bone diseases
* ongoing steroids treatment
* ongoing or in the previous 12 months treatment with bone anti-resorptive, amiodarone, colestyramine or iron.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No