Hypothyroidism
Conditions
Interventions
Study setting: Endocrine clinic, Colombo South Teaching Hospital, Sri Lanka
Method of allocation: Simple randomization using a pre-planned computer generated random table. Random table will be kept
Outcome assessors and data analysts will be blinded to the intervention status of the participants.
Sponsors
Dr. D.U.S Bulugahapitiya
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years and <70 years 2. Primary hypothyroidism due to autoimmune hypothyroidism, thyroidectomy or radioiodine treatment 3. Serum Thyroid-Stimulating Hormone (TSH) and free thyroxine (T4) are within normal range 4. No change in thyroxine dose in the past 3 months 5. Baseline blood pressure <140/90 mmHg 6. Baseline pulse rate <90 bpm 7. Adequate contraceptive measures for women of childbearing age 8. Meaningful consent is available
Exclusion criteria
Exclusion criteria: 1. Ischaemic heart disease (previous acute coronary syndrome, stable angina, coronary artery revascularization or evidence of cardiac ischaemia on ECG, exercise ECG or echocardiography) 2. Pre-existing heart failure or ejection fraction 140/90 mmHg) 5. Renal failure with eGFR 5 times upper limit of normal reference range 7. Bone fracture in past 3 months 8. Paget’s disease of bone 9. Malabsorption 10. Pregnancy 11. History of thyroid malignancy 12. Any terminal disease (eg. advanced heart failure, advanced respiratory disease, malignancy) 13. Not available for follow-up (e.g. no fixed address, unable to come for regular clinic follow-ups) 14. Participation in another clinical trial within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients maintained in euthyroid state 2. Mean TSH and free T4 3. Mean end-systolic diameter, end diastolic diameter and ejection fraction on echocardiogram 4. Mean Hyperthyroid Symptom Score (Klein et al, 1988) [1. End of the study period of 12 weeks 2. At the end of the study period of 12 weeks 3. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen. 4. 4 - 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean blood pressure 2. Mean heart rate 3. Incidence of cardiac complications (composite of tachyarrhythmias, stable angina, acute coronary syndromes, heart failure) 4. Incidence of biochemically confirmed thyrotoxicosis 5. Mean visual analogue Arizona Integrative Outcomes Scale (AIOS) score to assess patient well-being [1. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen 2. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen 3. During the study period of 12 weeks. 4. During the study period of 12 weeks 5. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. D.U.S Bulugahapitiya
Consultant Endocrinologist
Outcome results
None listed