- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627611
Identification of Non-responders to Levothyroxine Therapy
March 12, 2021 updated by: Erik Fink Eriksen, Oslo University Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Poorly regulated hypothyroidism
- Female aged between 18 and 65 years
- Written informed consent obtained from the patient according to national regulations
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: T4
|
3 months
|
Experimental: T3
|
3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brown adipose tissue activation
Time Frame: 6 months
|
Thermal imaging of supraclavicular fossa
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body temperature
Time Frame: 6 months
|
Rectal thermometer
|
6 months
|
Energy expenditure
Time Frame: 6 months
|
Indirect calorimetry
|
6 months
|
Muscle strength
Time Frame: 6 months
|
Hand grip test
|
6 months
|
ThyPRO Questionnaire
Time Frame: 6 months
|
Thyroid patient reported outcome, 13 multi-item scale, range 0-100 with higher scores indicating poorer health status
|
6 months
|
Mean levels of thyroid hormones
Time Frame: 6 months
|
TSH, free T4 and free T3
|
6 months
|
SF-36 Questionnaire
Time Frame: 6 months
|
Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status
|
6 months
|
Fatigue Questionnaire
Time Frame: 6 months
|
11 item, range 0-33 with higher scores implying higher levels of fatigue
|
6 months
|
New biomarkers
Time Frame: 6 months
|
Bone marrow fat, serum and urine
|
6 months
|
Micro-RNA, miR-92a
Time Frame: 6 months
|
Serum exosomes
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik Fink Eriksen, Professor, Department of Endocrinology, Morbid Obesity and Preventive Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bjerkreim 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.
- Bjerkreim 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2018
Primary Completion (Actual)
June 22, 2020
Study Completion (Actual)
June 22, 2020
Study Registration Dates
First Submitted
May 25, 2018
First Submitted That Met QC Criteria
August 10, 2018
First Posted (Actual)
August 13, 2018
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 12, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1883 (REK)
- 2017-003673-34 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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