HypothyroidismPhase 2NCT03627611
Identification of Non-responders to Levothyroxine Therapy
A Phase 2 study testing Levothyroxin and Liothyronine in people with Hypothyroidism and Biomarkers, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypothyroidism, Biomarkers, Endocrine System Diseases
- What is being tested?
- Levothyroxin and Liothyronine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNorway
- Study dates
- 14 Aug 2018to 22 Jun 2020
- Phase
- Phase 2
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poorly regulated hypothyroidism
- Female aged between 18 and 65 years
- Written informed consent obtained from the patient according to national regulations
Who cannot join
- Cardiovascular disease
- Chronic liver disease
- Chronic kidney disease
- Any other endocrinological disease
- Use of beta blockers
- Pregnant or lactating females
- Hormonal substitution other than T3 and T4
- Known psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine
The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level
Read the detailed description
15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine substitution. Endocrinologists are split in their opinion on combination therapy with T4 and T3 on patients with poorly regulated hypothyroidism. There are no objective means, by which to identify individuals who would benefit from combination therapy. The purpose of this study is to assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and brain function. The main aim is to try to identify biomarkers reflecting different effects of T4 and T3 on cell and tissue level.
- Conditions
- Hypothyroidism, Biomarkers, Endocrine System Diseases
- Being tested
- Levothyroxin, Liothyronine
- Keywords
- Thyroxine, Triiodothyronine
- Medical subject headings
- Hypothyroidism, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxinDrug
3 months
LiothyronineDrug
3 months
| Study group | Role | What they receive |
|---|---|---|
| T4 | Active comparator | Not described Receives: Drug: Levothyroxin |
| T3 | Experimental | Not described Receives: Drug: Liothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brown adipose tissue activation
Thermal imaging of supraclavicular fossa
Measured: 6 months
Secondary outcomes (9)
Body temperature
Rectal thermometer
Measured: 6 months
Energy expenditure
Indirect calorimetry
Measured: 6 months
Muscle strength
Hand grip test
Measured: 6 months
ThyPRO Questionnaire
Thyroid patient reported outcome, 13 multi-item scale, range 0-100 with higher scores indicating poorer health status
Measured: 6 months
Mean levels of thyroid hormones
TSH, free T4 and free T3
Measured: 6 months
SF-36 Questionnaire
Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status
Measured: 6 months
Fatigue Questionnaire
11 item, range 0-33 with higher scores implying higher levels of fatigue
Measured: 6 months
New biomarkers
Bone marrow fat, serum and urine
Measured: 6 months
Micro-RNA, miR-92a
Serum exosomes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start14 Aug 2018
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hormonlaboratoriet, Spesialistsenteret Pilestredet Park
- Responsible party
- Principal investigator, Erik Fink Eriksen, Oslo University Hospital
- Investigators
- Erik Fink Eriksen, Professor, Principal investigator, Department of Endocrinology, Morbid Obesity and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627611
- Sponsor's protocol ID
- 2017/1883 (REK)
- Other IDs
- 2017-003673-34, 2017
- Status last verified
- Mar 2021
- First submitted
- 25 May 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Lee-Odegard S, Eriksen EF. Thyroid Signaling Biomarkers in Female Symptomatic Hypothyroid Patients on Liothyronine versus Levothyroxine Monotherapy: A Randomized Crossover Trial. J Thyroid Res. 2022 May 4;2022:6423023. doi: 10.1155/2022/6423023. eCollection 2022.
PubMed 35572853Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Omdal LJ, Lee-Odegard S, Eriksen EF. Effect of Liothyronine Treatment on Quality of Life in Female Hypothyroid Patients With Residual Symptoms on Levothyroxine Therapy: A Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 Feb 22;13:816566. doi: 10.3389/fendo.2022.816566. eCollection 2022.
PubMed 35273566Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Lee-Odegard S, Rangberg A, Jonassen CM, Budge H, Morris D, Law J, Symonds M, Eriksen EF. Effect of Liothyronine Treatment on Dermal Temperature and Activation of Brown Adipose Tissue in Female Hypothyroid Patients: A Randomized Crossover Study. Front Endocrinol (Lausanne). 2021 Nov 19;12:785175. doi: 10.3389/fendo.2021.785175. eCollection 2021.
PubMed 34867829
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine
- ClinicalTrials.gov ID
- NCT03627611
- Acronym / sponsor ID
- 2017/1883 (REK)
- Conditions
- Hypothyroidism, Biomarkers, Endocrine System Diseases
- Keywords
- Thyroxine, Triiodothyronine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Hormonlaboratoriet, Spesialistsenteret Pilestredet Park
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 13 Aug 2018 (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 purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level
Detailed description
15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine substitution. Endocrinologists are split in their opinion on combination therapy with T4 and T3 on patients with poorly regulated hypothyroidism. There are no objective means, by which to identify individuals who would benefit from combination therapy. The purpose of this study is to assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and brain function. The main aim is to try to identify biomarkers reflecting different effects of T4 and T3 on cell and tissue level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T4 | Active comparator | Drug: Levothyroxin |
| T3 | Experimental | Drug: Liothyronine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Poorly regulated hypothyroidism
- Female aged between 18 and 65 years
- Written informed consent obtained from the patient according to national regulations
Key exclusion criteria (8 listed)
- Cardiovascular disease
- Chronic liver disease
- Chronic kidney disease
- Any other endocrinological disease
- Use of beta blockers
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 |
|---|---|---|
| Levothyroxin3 months | Drug | T4 |
| Liothyronine3 months | Drug | T3 |
Primary outcome
Brown adipose tissue activation
Time frame: 6 months
Thermal imaging of supraclavicular fossa
9 secondary outcomes
Body temperature
Time frame: 6 months
Energy expenditure
Time frame: 6 months
Muscle strength
Time frame: 6 months
ThyPRO Questionnaire
Time frame: 6 months
Mean levels of thyroid hormones
Time frame: 6 months
SF-36 Questionnaire
Time frame: 6 months
Fatigue Questionnaire
Time frame: 6 months
New biomarkers
Time frame: 6 months
Micro-RNA, miR-92a
Time frame: 6 months
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 17 Mar 2021.
- Derived from this study: PubMed 35572853Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Lee-Odegard S, Eriksen EF. Thyroid Signaling Biomarkers in Female Symptomatic Hypothyroid Patients on Liothyronine versus Levothyroxine Monotherapy: A Randomized Crossover Trial. J Thyroid Res. 2022 May 4;2022:6423023. doi: 10.1155/2022/6423023. eCollection 2022.
- Derived from this study: PubMed 35273566Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Omdal LJ, Lee-Odegard S, Eriksen EF. Effect of Liothyronine Treatment on Quality of Life in Female Hypothyroid Patients With Residual Symptoms on Levothyroxine Therapy: A Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 Feb 22;13:816566. doi: 10.3389/fendo.2022.816566. eCollection 2022.
- Derived from this study: PubMed 34867829Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Lee-Odegard S, Rangberg A, Jonassen CM, Budge H, Morris D, Law J, Symonds M, Eriksen EF. Effect of Liothyronine Treatment on Dermal Temperature and Activation of Brown Adipose Tissue in Female Hypothyroid Patients: A Randomized Crossover Study. Front Endocrinol (Lausanne). 2021 Nov 19;12:785175. doi: 10.3389/fendo.2021.785175. eCollection 2021.
Related trials for Hypothyroidism
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
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.
Erik Fink Eriksen, Professor principal investigator
Department of Endocrinology, Morbid Obesity and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levothyroxin and Liothyronine in people with Hypothyroidism and Biomarkers, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 8 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 17 Mar 2021. 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 Norway. 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 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.
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?
Brown adipose tissue activation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627611, which also lists 3 linked publications.
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 17 Mar 2021.