Health Condition 1: E039- Hypothyroidism, unspecified
Conditions
Interventions
Intervention1: Levothyroxine + Liothyronine: Levothyroxine (weight based dosing once daily per oral)+ Liothyronine (5 mcg once daily per oral)
Total duration: 6 months
Control Intervention1: Levothyro
Sponsors
Postgraduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-60 years 2. Treatment na ve overt primary (Autoimmune hypothyroidism and post-thyroidectomy due to multi-nodular goitre, and eu-parathyroidism in the post-thyroidectomy period) and central hypothyroidism (Due to non-functional pituitary adenoma, without any evidence of hormonal excess) 3. Capable of understanding and giving consent
Exclusion criteria
Exclusion criteria: 1. Pregnant patients or those planning pregnancy 2. History of cardiac disease (cardiac arrhythmias or coronary artery disease), chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and nonthyroidal active cancers, uncontrolled psychosis 3. Patient on drugs affecting metabolism or bioavailability of thyroid hormone, corticosteroids (taking more than replacement doses of corticosteroids), amiodarone, cholestyramine, psychotropic drugs, or chemotherapy 4. Patients with hypothyroidism due to radioactive iodine therapy 5. Patients with hypothyroidism post-surgery due to thyroid malignancy 6. Patients who had hypoparathyroidism post-thyroidectomy, requiring calcium supplementation 7. Patients already on thyroid replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving biochemical euthyroidism at 3 months, 4 months, and 6 months of the study periodTimepoint: 3 months, 4 months and 6 months are the time points | — |
Secondary
| Measure | Time frame |
|---|---|
| Time taken to achieve biochemical euthyroidism among the two groupsTimepoint: 3 months, 4 months, & 6 months;Time taken to achieve improvement in quality of lifeTimepoint: 3 months, 4 months, & 6 months;Percentage of patients showing improvement in quality of life at 1, 3, & 6 monthsTimepoint: 1 months, 3 months, & 6 months;Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) at the end of the study periodTimepoint: Baseline & 6 months;Change in sex hormone-binding globulin (SHBG) levels at the end of the study periodTimepoint: Baseline & 6 months;Change in bone turnover markers at the end of the study periodTimepoint: Baseline & 6 months;Change in body composition at the end of study periodTimepoint: Baseline & 6 months;Adverse events seen with the different therapy groupsTimepoint: 1 month, 3 months, & 6 months | — |
Countries
India
Contacts
Public ContactDr Pinaki Dutta
PGIMER Chandigarh
Outcome results
None listed