Hypothyroidism. Hypothyroidism, unspecified
Conditions
Interventions
Intervention 1: Tavan Institute and Dorsa Pharmaceutical Company will formulate SR-T3 tablets (15 µg). Iran Hormone Company produces 50, 75, and 100 µg levothyroxine tablets. The patients will be rand
1:5 ratio) and control groups. The tablets should be taken in the morning at least half an hour before breakfast. At the first visit, a fasting blood sample will be obtained at 8 am and the specified
Sponsors
Dorsa Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for Phase 2 and Phase 3 are the same as follows: Patients over 20 y. with hypothyroidism caused by any reason e.g. Hashimoto thyroiditis, treated Graves’ patients after radioactive iodine intake, total thyroidectomized patients due to thyroid cancer or congenital hypothyroidism, who take LT4 monotherapy for at least 3 months and attain euthyroid status (TSH=0.5-5 mU/L is optimal).
Exclusion criteria
Exclusion criteria: Exclusion criteria for Phase 2 and Phase 3 are the same as follows: Pregnant women, those with end-organ failure e.g. chronic kidney and liver disease, congestive heart failure, or any kind of cancer, having other cofactors that mimicked symptoms of hypothyroidism, including low Hb, 25[OH] D deficiency, vitamin B12 deficiency, having long-standing psychiatric disorders(e.g major depressive disorders) and fibromyalgia, because those can mask some of the hypothyroid symptoms (eg, fatigue, arthralgia, depression, cognitive slowing); will be excluded. The patients should avoid taking methimazole, PTU, Tamoxifen, and drug-containing estrogen, progesterone, and corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life. Timepoint: At baseline and 6 and 12 months after trial. Method of measurement: Thyroid-specific Patient-Reported Outcome short-form (ThyPRO-39) modeled for hypothyroid subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| SERUM TSH. Timepoint: At baseline and 3, 6, and 12 months after start-up. Method of measurement: on -20ºC stored serum samples by the electrochemiluminescence immunoasaay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).;Total T4, FREE T4, Total T3, T3/T4 ratio. Timepoint: At baseline and 3, 6, and 12 months after start-up. Method of measurement: electrochemiluminescence immunoasaay (ECLIA), Serum Total tri-iodothyronine(TT3), total thyroxine (TT4) will be determined on -20ºC stored serum samples by the electrochemiluminescence immunoasaay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).;Clinical signs and symptoms of hypothyroidism. Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: thyroid symptom questionnaire.;Serum Lipid Profile(TG,HDL,LDL, TOTAL CHOLESTROL). Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: Laboratory measurements with related kits.;FBS, Insulin sensitivity (HbA1C, HOMA-IR). Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: Laboratory measurements with related kits.;Sex Hormone Binding Globulin (SHBG). Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: Laboratory measurements with related kits.;Muscle thyroid status (Enolase, LDH and CK),. Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: Laboratory measurements with related kits.;Ferritin. Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: Laboratory measurements with related kits.;Metabolomics. Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: Laboratory measurements with related kits.;Cardiac parameters (resting heart rate, BP). Timepoint: At baseline, 6 and 12 months after intervention. Method of measurement: With related measures | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLadan Mehran
Shahid Beheshti University of Medical Sciences
Outcome results
None listed