NCT03053115

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Azienda USL Modena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothyroidism

Interventions

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

Timeline

• Start date: 2017-03-14
• Primary completion: 2021-09-05
• Completion: 2022-06-30
• First posted: 2017-02-14
• Last updated: 2023-04-21

Locations

1 site across 1 country: Italy