Skip to content

Weekly-based LT4 dosing in hypothyroidism

Alternate-Dosing Daily on Total Weekly Dose Basis Versus Fixed Daily Dosing of Levothyroxine in Adults with Hypothyroidism: A Randomized Controlled Open-Label Cross-over Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251128009
Enrollment
24
Registered
2025-11-28
Start date
2025-09-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Levothyroxine is the standard treatment for hypothyroidism, idealistically prescribed as a fixed daily dose. However, in Thailand and similar settings, the limited availability of tablet strengths makes it difficult to fine-tune doses for individual patients. This often leads to under- or overtreatment. An alternate-dosing regimen, based on total weekly dose, may offer more flexibility and maintain stable thyroid hormone levels. The study aims to evaluate whether this method is as effective and

Interventions

- Daily levothyroxine with variable doses (based on available tablet strengths: 50 mcg and 100 mcg). - Designed to achieve an equivalent total weekly dose. - Adjustment within +/- 5 % of the calculate
Active Comparator Drug,Active Comparator Drug
Alternate-Dosing Regimen,Fixed-Dosing Regimen

Sponsors

Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years 2. Diagnosed with hypothyroidism 3. Admitted to Ramathibodi Hospital for total thyroidectomy due to a benign condition, or currently receiving levothyroxine therapy for hypothyroidism 4. Requires levothyroxine as thyroid hormone replacement

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding individuals 2. Presence of uncontrolled medical conditions that could affect thyroid function 3. History of or newly diagnosis of thyroid cancer 4. Known allergy or intolerance to levothyroxine or its components 5. Inability to comply with the study protocol or follow-up requirements 6. Acute illness required hospitalization (unrelated to thyroidectomy) in the last 90 days 7. Diagnosis of liver cirrhosis (any stages) 8. Abnormal liver function tests (AST/ALT > 3 times the upper limit of normal or albumin < 2.5 g/dL) in the last 90 days 9. eGFR < 30 mL/min/1.73 m2 10. Receive levothyroxine 100 mcg/day as initiating dose

Design outcomes

Primary

MeasureTime frame
Thyroid stimulating hormone (TSH) 8th and 16th week mIU/L

Secondary

MeasureTime frame
Free thyroxine 4 (FT4) 8th and 16th week ng/dL,Clinical symptoms 8th and 16th week physician assessment,patient satisfactoriness 8th and 16th week patient self assessment,patient preference at the end of trial patient self assessment

Countries

Thailand

Contacts

Public ContactJiradej Tesriprasert

Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

jiradej.tes@gmail.com0864153455

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026