Improvement in treatment of hypothyroidism using slow-release Liothyronine

Randomized control Clinical Trial to assess the efficacy of the three different combined preparations of levothyroxine plus slow-release liothyronine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100922004794N13

Enrollment

Registered

2021-12-08

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Hypothyroidism. Hypothyroidism, unspecified

Interventions

Intervention 1: Intervention group 1: Taking 75µg LT4 Tab. plus 7.5µg SR-T3 Tab (ratio 1:10). Dorsa Pharmaceutical Company, Tavan Institute, will formulate these tablets. The

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: Hypothyroid patients over 20 yrs. due to radioactive iodine intake for treating Graves’ Disease, who attained euthyroid status with LT4 monotherapy (TSH=0.5-5 mU/L is optimal).

Exclusion criteria

Exclusion criteria: Pregnancy, chronic kidney or liver disease, congestive heart failure, cancer, taking methimazole, PTU, Tamoxifen, estrogen, progesterone, and corticosteroids

Design outcomes

Primary

Measure	Time frame
T3/T4 ratio. Timepoint: 8 weeks after intervention. Method of measurement: Serum Total tri-iodothyronine(TT3), total thyroxine (TT4) will be determined on -20ºC stored serum samples by the electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).	—

Secondary

Measure	Time frame
Serum TSH and Free T4 concentrations. Timepoint: At the baseline and end of the study. Method of measurement: On -20ºC stored serum samples by the electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).;Serum Lipid Profile. Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;FBS, LDH, CK, ferritin. Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;Metabolomics. Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;Cardiac parameters (ECG, resting heart rate, BP). Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;Treatment satisfaction. Timepoint: At the first and last visits. Method of measurement: Treatment satisfaction questionnaire (THY-TSQ).;Thyroid symptoms. Timepoint: At the first and last visits. Method of measurement: Thyroid symptom questionnaire.	—

Measure

Time frame

Serum TSH and Free T4 concentrations. Timepoint: At the baseline and end of the study. Method of measurement: On -20ºC stored serum samples by the electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).;Serum Lipid Profile. Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;FBS, LDH, CK, ferritin. Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;Metabolomics. Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;Cardiac parameters (ECG, resting heart rate, BP). Timepoint: At the baseline and end of the study. Method of measurement: Laboratory measurements with the related kits.;Treatment satisfaction. Timepoint: At the first and last visits. Method of measurement: Treatment satisfaction questionnaire (THY-TSQ).;Thyroid symptoms. Timepoint: At the first and last visits. Method of measurement: Thyroid symptom questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Mehran

Shahid Beheshti University of Medical Sciences

lmehran@endocrine.ac.ir+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026