Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism

Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00531713

Acronym

T4-T3

Enrollment

Registered

2007-09-19

Start date

2003-04-30

Completion date

2007-03-31

Last updated

2007-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Depression

Keywords

hypothyroidism, quality og life, depression

Brief summary

To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

Detailed description

double blind randomized cross-over study.

Interventions

DRUGTriiodothyronine

50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Hypothyroidism, S-TSH\> 20 at diagnosis,Anti-TPO \>300 Normal TSH (0,4-4,0) for 6 months.

Exclusion criteria

* \<18 år * \>75 år * pregnant women * Thyroid cancer * T3 treatment * Post-partum thyroiditis

Design outcomes

Primary

Measure	Time frame
Selv-rating scales: SF-36, SCL -90-R, BDI	3 month treating

Secondary

Measure	Time frame
BMI, bioimpedance	3 month treament

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026