Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT03053115
• Date of registration: 25/11/2016
• Prospective Registration: Yes
• Primary sponsor: Azienda USL Modena
• Public title: Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients LEVOLIO
• Scientific title: Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study
• Date of first enrolment: March 14, 2017
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03053115
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypothyroidism

Intervention(s)

Drug: Levothyroxin

Drug: Liothyronine

Drug: Placebos

Primary Outcome(s)

change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

Secondary Outcome(s)

change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

BMI (kg/m2) [Time Frame: baseline and then repeated at 6, 12 weeks and 24 weeks]

change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline Osteocalcin at 12 and 24 weeks (ng/mL) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L) [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

quality of life changes [Time Frame: baseline and then repeated at 12 weeks and 24 weeks]

Secondary ID(s)

EudraCT: 2016-000687-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors