Comparison of L-Thyroxine plus Liothyronine with L-thyroxine alone in post-surgical hypothyroidism

A Randomized Controlled Trial comparing L-Thyroxine plus Liothyronine with L-thyroxine alone in post-surgical hypothyroidism

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002600

Enrollment

200

Registered

2017-12-15

Start date

2018-04-27

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : T4 (levothyroxine) monotherapy (active ontrol) vs. T4(levothyroxine)/T3 (tetronine) combination therapy : Study drug - T4 7.5mcg as one tablet /T3 2.5mcg as one tablet(which have same shape an

T4 75mcg+study drug T4 7.5mcg B vs. T4 75mcg + study drug T3 2.5mcg B T4 100mcg -&gt

T4 85.7mcg + study drug T4 7.5mcg B vs. T4 85.7mcg + study drug T3 2.5mcg B T4 114mcg -&gt

T4 100mcg + study drug T4 7.5mcg B vs. T4 100mcg + study drug T3 2.5mcg B T4 125mcg -&gt

T4 100mcg + study drug T4 7.5mcg 1T at morning - 15mcg(2T) at evening vs. T4 100mcg + study drug T3 2.5mcg 1T at morning - 5mcg (2T) at evening T4 150mcg -&gt

T4 125mcg + study drug T4 7.5mcg 1T at morning - 15mcg(2T) at evening vs. T4 125mcg + study drug T3 2.5mcg 1T at morning - 5mcg (2T) at evening : These study durgs will be prescribed for 3 months

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: s/p Total thyroidectomy d/t thyroid cancer Postoperative period 2yr-10yr no evidence of residual disease : non-stimulated Tg <0.2 ng/mL, US (-) Normalized thyroid function (TSH 0.1-5.0 mIU/L) with daily T4 dose ranging from 85.7mcg -150mcg : stable thyroid function in repeated thyroid function test over 6 months interval one of subjective persistent symptoms below compared to preoperative period [1] • fatigue or lethargic (0-4) • body weight gain (0-4) • generalized body pain or ache (0-4) • clumsiness (0-4) ? (These symptoms should be persistent at least 6 months recently. ? Patients with scores = 2 for one of each symptom considered to have subjective symptoms.)

Exclusion criteria

Exclusion criteria: Person who can not fill in the questionnaire by oneself Pregnancy Uncontrolled heart/liver/kidney disease, anemia (Hb <11) Psychiatric ds/mood disorder Other cancers, DM on insulin injection, dyslipidemia on statin Previous history of combination therapy, within 1 year Underlying autoimmune thyroid ds (TPO+ or lymphocytic thyroiditis in pathology)

Design outcomes

Primary

Measure	Time frame
Changes in the scores of quality of life questionnaires from the 1st visit to the last visit : Multidimensional fatige inventory, short form 36-item health survey	—

Secondary

Measure	Time frame
Changes in self-reported symptoms (5-point scale), Patient preference, Changes in biochemical parameters, Assessment of changing trend of scores from quality of life by questionnaires	—

Countries

Korea, Republic of

Contacts

Public ContactMin Ji Jeon

Asan Medical Center

mj080332@gmail.com+82-2-3010-1317

Outcome results