Assessment of efficacy and safety of Thyroxine Sodium in Indian Patients with Primary Hypothyroidism

Phase 4

Completed

Brief Summary: This is a prospective, single center, open-label, non-comparative study designed to evaluate effectiveness and safety of Thyroxine Sodium in treatment naÃ¯ve patients newly diagnosed with primary hypothyroidism.

The study population will include treatment naÃ¯ve patients with newly diagnosed primary hypothyroidism, with TSH level >10 mIU/L and fT4 level < 0.8 ng/dl; meeting inclusion and exclusion criteria, and ready to give informed consent for study participation. Selection of patients for the study will be totally at the discretion of investigators.

At baseline severity of disease will be assessed using Zulewski scale score. Patients will be prescribed Thyroxine Sodium at a dose of 1.7mcg/kg daily for 45 days. The dose will be escalated or titrated, based on progress patient is making after receiving Thyroxine Sodium at Follow-up Visit 1 (45 days) and/or at follow-up visit 2 (90 days) based on the TSH level. All patients will be followed up to a period of 180 days, after enrollment into the study.

Recruitment & Eligibility

Inclusion Criteria

Treatment naÃ¯ve patients newly diagnosed with primary hypothyroidism 2.
Patient with TSH level >10 mIU/L 3.
Patients with fT4 level < 0.8 ng/dl 4.
Patients willing to participate in the study, sign the Informed Consent Form (ICF) and ready to comply with protocol requirements.

Exclusion Criteria

Patients with primary hypothyroidism who are already on treatment with thyroxine for more than a month 2.
Pregnant and/or lactating women 3.
Patients with any acute or chronic cardiac or any other systemic illness that in the opinion of the investigator does not justify the patientâ€™s inclusion in the study.

Primary Outcome Measures

Name	Time	Method
1 Number and percentage of patients with normalization in TSH & fT4 levels over a period of 180 days (6 months)	Baseline (Day 0) \| 45 days \| 90 days \| 180 days

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the effectiveness of thyroxine sodium in improving Zulewski score at 45, 90 and 180 days, compared to baseline	2. To evaluate the pattern of dose modification of thyroxine sodium at 45 and 90 days

Locations (4): Cedar Superspeciality Clinics
🇮🇳
West, DELHI, India
Dr. Khandelwals Diabetes & Endocrinology Clinic
🇮🇳
West, DELHI, India
F S Endocrine and Diabetes center
🇮🇳
Hyderabad, TELANGANA, India
Karnawat Speciality Clinic and Diagnostic Centre
🇮🇳
Nashik, MAHARASHTRA, India
Cedar Superspeciality Clinics
🇮🇳West, DELHI, India
Dr Deep Dutta
Principal investigator
8920600220
deepdutta2000@yahoo.com