NCT03627611

Brief Summary

The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

May 25, 2018

Last Update Submit

March 12, 2021

Conditions

HypothyroidismBiomarkersEndocrine System Diseases

Keywords

ThyroxineTriiodothyronine

Outcome Measures

Primary Outcomes (1)

  • Brown adipose tissue activation

    Thermal imaging of supraclavicular fossa

    6 months

Secondary Outcomes (9)

  • Body temperature

    6 months

  • Energy expenditure

    6 months

  • Muscle strength

    6 months

  • ThyPRO Questionnaire

    6 months

  • Mean levels of thyroid hormones

    6 months

  • +4 more secondary outcomes

Study Arms (2)

T4

ACTIVE COMPARATOR
Drug: Levothyroxin

T3

EXPERIMENTAL
Drug: Liothyronine

Interventions

LevothyroxinDRUG

3 months

T4
LiothyronineDRUG

3 months

T3

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Poorly regulated hypothyroidism
  • Female aged between 18 and 65 years
  • Written informed consent obtained from the patient according to national regulations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (3)

  • 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.

    PMID: 35572853DERIVED

  • 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.

    PMID: 35273566DERIVED

  • 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.

    PMID: 34867829DERIVED

MeSH Terms

Conditions

HypothyroidismEndocrine System Diseases

Interventions

ThyroxineTriiodothyronine

Condition Hierarchy (Ancestors)

Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsThyronines

Study Officials

  • Erik Fink Eriksen, Professor

    Department of Endocrinology, Morbid Obesity and Preventive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2018

First Posted

August 13, 2018

Study Start

August 14, 2018

Primary Completion

June 22, 2020

Study Completion

June 22, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

NO(1)