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

Copenhagen University Hospital at Herlev

Status and phase: Completed; Phase 4

Conditions: Quality of Life; Depression

Treatments: Drug: Triiodothyronine

Study type: Interventional

Funder types: Other

Identifiers

NCT00531713

KA 02022ms

T4-T3 hypothyreose

Details and patient eligibility

About

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

Full description

double blind randomized cross-over study.

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

59 participants in 2 patient groups

1

No Intervention group

Description:

Usual T4 dose is given

2

Active Comparator group

Description:

20 microgram of T3 is given and 50 microgram of T4 is withdrawn

Treatment:

Drug: Triiodothyronine