Health Condition 1: null- patients diagnosed with hypothyroidism based on laboratory parameters and on treatment with levothyroxine
Conditions
Interventions
Intervention1: Group B: hypothyroid patients on levothyroxine 1.6mcg/kg dose,oral, two hours after dinner
Control Intervention1: Group A: hypothyroidism patients on levothyroxine 1.6mcg/kg dose, half
Sponsors
Dr Reena Sherin Parveen
Eligibility
Inclusion criteria
Inclusion criteria: Known hypothyroid patients on more than 1.6mcg/kg dose of levothyroxine, unchanged for last 3 months with TSH value in the laboratory reference range in the preceding 6 months.
Exclusion criteria
Exclusion criteria: Patients with • History of major gastro-intestinal disease. • History of taking any medication known to interfere with levothyroxine absorption.( bile acid sequestrants, ferrous sulphate, sucralfate, calcium carbonate, aluminium-containing antacids, phosphate binders, raloxifene and proton-pump inhibitors) • Chronic liver and renal disease. • Pregnant and lactating women. • Severe acute illness or severe trauma in the last 3 months. • Major surgery, 3 months prior to Visit 1. • Significant cardiovascular or cerebrovascular disease. • Known muscular or neuromuscular disease . • Neoplastic disease. • Signs of mental dysfunction or other factors likely to limit ability to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To determine the effect of changing the timings of levothyroxine administration on the TSH levels of subjects with primary hypothyroidism, thereby assessing whether evening dose is as efficacious as the morning doseTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To assess the impact of change in timing on the patientâ??s symptoms using thyroid symptom questionnaireTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Princy L Palatty
Father Muller Medical College
Outcome results
None listed