Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

Hypothyroidism Clinical Trial

— LEVOLIO  

Official title:

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053115
• Other study ID #: EudraCT: 2016-000687-41
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 14, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2023
• Source: Azienda USL Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 30, 2022
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• Liothyronine
Cases will take liothyronine drops in the morning and two hours after dinner
• Levothyroxin
Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)
• Placebos
Controls will take placebo two hours after dinner

Locations

Country	Name	City	State
Italy	AziendaUSLModena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)	change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	BMI (kg/m2)	body mass index	baseline and then repeated at 6, 12 weeks and 24 weeks
Secondary	quality of life changes	score at validated questionnaires	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml)	change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)	change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)	change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)	change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)	change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl)	change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)	change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)	change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)	baseline and then repeated at 12 weeks and 24 weeks
Secondary	change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L)	change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L)	baseline and then repeated at 12 weeks and 24 weeks