Skip to content

New method of levothyroxine dose estimation in primary Hypothyroidism

Comparison of a formula based levothyroxine dose with the conventional dose in newly diagnosed primary hypothyroidism: A Randomized, Parallel Group, Active Controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034565
Enrollment
152
Registered
2021-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E038- Other specified hypothyroidism

Interventions

Intervention1: Levothyroxine: Levothyroxine dose Dose per day 11 add 13 multiply 1 for female and 2 for male and half of serum TSH Intervention2: New formula based arm: Dose per day 11 add 13 multi

Sponsors

Principal Investigator
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age above 18 years and 2.Newly diagnosed with primary hypothyroidism (overt and subclinical hypothyroidism) 3.Treatment-na�¯ve (not started on thyroid hormone treatment)

Exclusion criteria

Exclusion criteria: 1.Pregnancy, 2.Central hypothyroidism, 3.Within two years of post-radiotherapy or radioiodine ablation, 4.Post total thyroidectomy cases, 5.Major co-morbidities, 6.Co-prescription of treatment known to affect thyroid hormone metabolism.

Design outcomes

Primary

MeasureTime frame
Euthyroidism at follow up We expect around 60 percent of the participants will achieve euthyroidism at first visit based on calculated doseTimepoint: follow up will be at 6-12 weeks after starting dose and each dose adjustment

Secondary

MeasureTime frame
To estmate the incidence of Iatrogenic thyrotoxicosis in both armsTimepoint: At the 1st follow-up between 4-8 weeks of starting levothyroxine

Countries

India

Contacts

Public ContactRekha Singh

All India Institute of Medical Sciences Bhopal

rekha.endo@gmail.com07552835061

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026