Health Condition 1: E039- Hypothyroidism, unspecified
Conditions
Interventions
Intervention1: Levothyroxine: Weekly once oral Levothyroxine 1000 mcg for 12 weeks
Control Intervention1: Levothyroxine: Daily once oral Levothyroxine 2mg/kg body weight per day for 12 weeks
Sponsors
Dept of Endocrinology
Eligibility
Inclusion criteria
Inclusion criteria: 1] Diagnosed cases of Hypothyroidism 2] TSH levels consistently above 10 mIU/L over a period of 6 months, while on treatment with daily oral Levothyroxine at a dose of 2.5mcg/kg/day or more 3]Patients willing to give consent for the study
Exclusion criteria
Exclusion criteria: 1] Patients admitting poor compliance or inadequate spacing before food intake or improper storage 2] Drugs known to interfere with Thyroxine absorption 3] Malabsorption disorders 4] Previous history of Bowel surgery 5} Inflammatory Bowel Disease 6] Nephrotic syndrome 7] Pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical adverse end points such as all cause mortality, acute coronary syndrome, cardiac arrythmia, heart failure intracranial hypertensionTimepoint: Baseline, 4 weeks, 8 weeks & 12 weeks from randomization & the start of therapy | — |
Primary
| Measure | Time frame |
|---|---|
| TSH levels less than 5 mIU/L with efficacy evaluated as the difference between the proportion [percentage] of subjects in the intervention arm and control arm who have TSH levels less than 5 mIU/L by 12 weeks from the start of interventionTimepoint: 12 weeks from the start of intervention | — |
Countries
India
Contacts
Public ContactDr Nevin S
Osmania Medical College
Outcome results
None listed