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CompletedNCT03053115LEVOLIOUpdated Apr 21, 2023

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

A Phase 2/3 interventional study of Liothyronine and Levothyroxin in Hypothyroidism, sponsored by Azienda USL Modena. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Azienda USL Modena · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypothyroidism

Keywords

  • thyroid
  • levothyroxine
  • combined therapy
03

In context

Hypothyroidism

217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.

This study's enrollment of 160 is above the median of 70 across 109 interventional studies indexed under Hypothyroidism.

Browse Hypothyroidism studies →

Lead sponsor

Azienda USL Modena is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • TSH suppressive therapy
  • pregnancy
  • cardiac arrhythmias
  • severe liver, kidney or bone diseases
  • ongoing treatment
  • ongoing or in the previous 12 months treatment with bone anti-resorptive, amiodarone, colestyramine or iron.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    CASES

    treatment with levothyroxine and liothyronine

    Drug: Liothyronine · Drug: Levothyroxin

  • Active comparator
    CONTROLS

    treatment with levothyroxine and placebo

    Drug: Levothyroxin · Drug: Placebos

Interventions

  • DrugLiothyronine

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

  • DrugLevothyroxin

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

  • DrugPlacebos

    Controls will take placebo two hours after dinner

06

What researchers measure

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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

Secondary outcomes

  1. BMI (kg/m2)

    body mass index

    Time frame: baseline and then repeated at 6, 12 weeks and 24 weeks

  2. quality of life changes

    score at validated questionnaires

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  3. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  4. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  5. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  6. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  7. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  8. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  9. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  10. change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)

    change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

  11. 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)

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

07

Study locations

1 site
  • AziendaUSLModena
    Modena, 41126, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Sep 2021, 53 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2016
First posted
Feb 14, 2017
StartActual
Mar 14, 2017
Primary completionActual
Sep 5, 2021
CompletionActual
Jun 30, 2022
Last update
Apr 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03053115
Lead sponsor
Azienda USL Modena
Responsible party
Manuela Simoni (Director of the Unit of Endocrinology, Azienda USL Modena) — Principal investigator
First posted
Feb 14, 2017
Start date
Mar 14, 2017
Primary completion
Sep 5, 2021
Completion
Jun 30, 2022
Last update
Apr 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Triiodothyronine

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