HypothyroidismPhase 2/3LEVOLIONCT03053115
Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients
A Phase 2/3 study testing Liothyronine and Levothyroxin in people with Hypothyroidism, run by Azienda USL Modena at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Liothyronine and Levothyroxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2017to 30 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study
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
- Being tested
- Liothyronine, Levothyroxin, Placebos
- Keywords
- thyroid, levothyroxine, combined therapy
- Medical subject headings
- Hypothyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiothyronineDrug
Cases will take liothyronine drops in the morning and two hours after dinner
LevothyroxinDrug
Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)
PlacebosDrug
Controls will take placebo two hours after dinner
| Study group | Role | What they receive |
|---|---|---|
| CASES | Experimental | treatment with levothyroxine and liothyronine Receives: Drug: Liothyronine; Drug: Levothyroxin |
| CONTROLS | Active comparator | treatment with levothyroxine and placebo Receives: Drug: Levothyroxin; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and then repeated at 12 weeks and 24 weeks
Secondary outcomes (11)
BMI (kg/m2)
body mass index
Measured: baseline and then repeated at 6, 12 weeks and 24 weeks
quality of life changes
score at validated questionnaires
Measured: baseline and then repeated at 12 weeks and 24 weeks
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)
Measured: 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)
change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)
Measured: 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)
change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)
Measured: baseline and then repeated at 12 weeks and 24 weeks
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)
Measured: baseline and then repeated at 12 weeks and 24 weeks
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)
Measured: baseline and then repeated at 12 weeks and 24 weeks
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)
Measured: 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)
change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)
Measured: baseline and then repeated at 12 weeks and 24 weeks
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
Measured: baseline and then repeated at 12 weeks and 24 weeks
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)
Measured: baseline and then repeated at 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start14 Mar 2017
- Primary completion5 Sep 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Simoni, Azienda USL Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053115
- Sponsor's protocol ID
- EudraCT: 2016-000687-41
- Acronym
- LEVOLIO
- Status last verified
- Apr 2023
- First submitted
- 25 Nov 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT03053115
- Acronym / sponsor ID
- LEVOLIO / EudraCT: 2016-000687-41
- Conditions
- Hypothyroidism
- Keywords
- thyroid, levothyroxine, combined therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASES | Experimental | Drug: Liothyronine, Drug: Levothyroxintreatment with levothyroxine and liothyronine |
| CONTROLS | Active comparator | Drug: Levothyroxin, Drug: Placebostreatment with levothyroxine and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- TSH suppressive therapy
- pregnancy
- cardiac arrhythmias
- severe liver, kidney or bone diseases
- ongoing steroids treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiothyronineCases will take liothyronine drops in the morning and two hours after dinner | Drug | CASES |
| LevothyroxinBoth cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases) | Drug | CASES, CONTROLS |
| PlacebosControls will take placebo two hours after dinner | Drug | CONTROLS |
Primary outcome
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
change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
11 secondary outcomes
BMI (kg/m2)
Time frame: baseline and then repeated at 6, 12 weeks and 24 weeks
quality of life changes
Time frame: baseline and then repeated at 12 weeks and 24 weeks
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
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
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 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 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Liothyronine and Levothyroxin in people with Hypothyroidism, run by Azienda USL Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.