Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients (LEVOLIO)

Azienda USL Modena

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypothyroidism

Treatments: Drug: Levothyroxin; Drug: Liothyronine; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03053115

EudraCT: 2016-000687-41

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

CASES

Experimental group

Description:

treatment with levothyroxine and liothyronine

Treatment:

Drug: Levothyroxin

Drug: Liothyronine

CONTROLS

Active Comparator group

Description:

treatment with levothyroxine and placebo

Treatment:

Drug: Levothyroxin

Drug: Placebos