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

Primary Purpose

Hypothyroidism

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Liothyronine
Levothyroxin
Placebos
Sponsored by
Azienda USL Modena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothyroidism focused on measuring thyroid, levothyroxine, combined therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AziendaUSLModena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CASES

CONTROLS

Arm Description

treatment with levothyroxine and liothyronine

treatment with levothyroxine and placebo

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

BMI (kg/m2)
body mass index
quality of life changes
score at validated questionnaires
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)
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)
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)
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)
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)
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)
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)
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
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)

Full Information

First Posted
November 25, 2016
Last Updated
April 19, 2023
Sponsor
Azienda USL Modena
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1. Study Identification

Unique Protocol Identification Number
NCT03053115
Brief Title
Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients
Acronym
LEVOLIO
Official Title
Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
September 5, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL Modena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
thyroid, levothyroxine, combined therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CASES
Arm Type
Experimental
Arm Description
treatment with levothyroxine and liothyronine
Arm Title
CONTROLS
Arm Type
Active Comparator
Arm Description
treatment with levothyroxine and placebo
Intervention Type
Drug
Intervention Name(s)
Liothyronine
Intervention Description
Cases will take liothyronine drops in the morning and two hours after dinner
Intervention Type
Drug
Intervention Name(s)
Levothyroxin
Intervention Description
Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Controls will take placebo two hours after dinner
Primary Outcome Measure Information:
Title
change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
Description
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 Measure Information:
Title
BMI (kg/m2)
Description
body mass index
Time Frame
baseline and then repeated at 6, 12 weeks and 24 weeks
Title
quality of life changes
Description
score at validated questionnaires
Time Frame
baseline and then repeated at 12 weeks and 24 weeks
Title
change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml)
Description
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
Title
change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)
Description
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
Title
change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)
Description
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
Title
change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)
Description
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
Title
change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)
Description
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
Title
change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl)
Description
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
Title
change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)
Description
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
Title
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
Description
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
Time Frame
baseline and then repeated at 12 weeks and 24 weeks
Title
change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
AziendaUSLModena
City
Modena
ZIP/Postal Code
41126
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

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