NCT03053115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

4.5 years

First QC Date

November 25, 2016

Last Update Submit

April 19, 2023

Conditions

Hypothyroidism

Keywords

thyroidlevothyroxinecombined therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • BMI (kg/m2)

    baseline and then repeated at 6, 12 weeks and 24 weeks

  • quality of life changes

    baseline and then repeated at 12 weeks and 24 weeks

  • change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml)

    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)

    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)

    baseline and then repeated at 12 weeks and 24 weeks

  • +6 more secondary outcomes

Study Arms (2)

CASES

EXPERIMENTAL

treatment with levothyroxine and liothyronine

Drug: LiothyronineDrug: Levothyroxin

CONTROLS

ACTIVE COMPARATOR

treatment with levothyroxine and placebo

Drug: LevothyroxinDrug: Placebos

Interventions

LiothyronineDRUG

Cases will take liothyronine drops in the morning and two hours after dinner

CASES
LevothyroxinDRUG

Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)

CASESCONTROLS
PlacebosDRUG

Controls will take placebo two hours after dinner

CONTROLS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AziendaUSLModena

Modena, 41126, Italy

Location

MeSH Terms

Conditions

HypothyroidismThyroid Diseases

Interventions

TriiodothyronineThyroxine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Unit of Endocrinology

Study Record Dates

First Submitted

November 25, 2016

First Posted

February 14, 2017

Study Start

March 14, 2017

Primary Completion

September 5, 2021

Study Completion

June 30, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

IT(1)