NCT06073665

Dosing of LT4 in Older Individuals

Levothyroxine Dosing in Older Individuals

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

Detailed description

Investigators will perform a randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4) in patients aged 65 years and older who are already taking a stable dose of at least 1.2 mcg/kg/day of LT4 therapy, one to maintain a target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L (lower TSH group) and another of a lower levothyroxine dose to achieve a target TSH of 5.5-7.0 mU/L (higher TSH group). Investigators will assess the effects of levothyroxine therapy at two different TSH targets on symptoms of hypothyroidism, mood, sleep, measures of memory and executive function, weight, lipids, and a marker of bone turnover.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
DRUG	Levothyroxine Sodium	Levothyroxine dose will depend on dose at baseline and randomization group

Timeline

• Start date: 2024-01-31
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-10-10
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study