Identification of Non-responders to Levothyroxine Therapy

University of Oslo (UIO) logo

University of Oslo (UIO)

Status and phase

Completed
Phase 2

Conditions

Biomarkers
Hypothyroidism
Endocrine System Diseases

Treatments

Drug: Levothyroxin
Drug: Liothyronine

Study type

Interventional

Funder types

Other

Identifiers

NCT03627611
2017/1883 (REK)
2017-003673-34 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

69 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

69 participants in 2 patient groups

T4
Active Comparator group
Treatment:
Drug: Levothyroxin
T3
Experimental group
Treatment:
Drug: Liothyronine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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