Penn Medicine, Smilow Translational Research Center
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT06073665
Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Levothyroxine dose will depend on dose at baseline and randomization group
Time frame: 6 months
22 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
4 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
Adjusted scale score, based around median of 100, higher scores indicated higher function
Time frame: 6 months
30 items, higher scores indicate more depressive symptoms
Time frame: 6 months
19 items, range of 0-21, higher scores indicate worse sleep
Time frame: 6 months
kilograms
Time frame: 6 months
blood test, g/dL
Time frame: 6 months
Participants will be asked if they can guess their randomization status and satisfaction with randomization status
Time frame: 6 months
Beck Anxiety Inventory, 21 items, range 0-63, higher scores indicate more anxiety
Time frame: 6 months
Blood test, pg/mL
Contact information is provided by the study sponsor or research team.
Anne R. Cappola, M.D., Sc.M.
CONTACT
Theresa M. Scattergood, M.S.N., R.N.
CONTACT
University of Pennsylvania
Other
Levothyroxine Dosing in Older Individuals
Acronym: DOT4
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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