Clinical Trial: Dosing of LT4 in Older Individuals

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL

Official Title: Levothyroxine Dosing in Older Individuals

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

Detailed Summary: 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.
Sponsor: University of Pennsylvania

Current Primary Outcome: 22 items, scored 0-100, higher scores indicate worse status

Original Primary Outcome: 22 items, scored 0-100, higher scores indicate worse status

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: September 22, 2023
Date Started: November 15, 2023
Date Completion: November 15, 2023
Last Updated: October 23, 2023
Last Verified: October 01, 2023