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Hormone Therapy

Levothyroxine Dosing for Hypothyroidism in Older Adults (DOT4 Trial)

Q: To what degree can elevated TSH levels prove detrimental to individuals?

<p>Our team at Power gives a rating of 3 to the Higher TSH group, signifying that this treatment has been approved and is safe.</p>

Q: Does this experiment currently have any openings for volunteers?

<p>According to clinicaltrials.gov this trial is not currently seeking participants, with its first posting being made on October 1st 2023 and its last update occurring a day later. This notwithstanding, there are 18 other medical trials actively recruiting right now.</p>

Phase 4

Recruiting

Led By Anne R. Cappola, M.D., Sc.M.

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

DOT4 Trial Summary

This trial will explore if adjusting thyroid hormone levels in elderly people helps them feel better. #ClinicalTrial #LT4 #Thyroid

Who is the study for?

This trial is for community-dwelling individuals aged 65 or older who have been diagnosed with hypothyroidism for at least 6 months, are on a stable dose of Levothyroxine Sodium (75-200 mcg per day), and can take oral medication. They must be able to follow the study procedures throughout its duration. People with hypopituitarism, history of thyroid cancer requiring TSH suppression, severe kidney issues (GFR <30), or those taking certain thyroid medications cannot participate.Check my eligibility

What is being tested?

The trial aims to explore the effects of more flexible dosing schedules of Levothyroxine Sodium (LT4) in older adults with hypothyroidism. It will assess how different dosing regimens might impact overall health and management of the condition.See study design

What are the potential side effects?

While not explicitly stated here, common side effects associated with Levothyroxine Sodium may include heart palpitations, increased appetite, weight loss, heat sensitivity, excessive sweating, and nervousness.

DOT4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with hypothyroidism for at least 6 months and am on a stable dose of thyroid medication.

DOT4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale

Secondary outcome measures

Beck Anxiety Inventory

Geriatric Depression Scale

LDL cholesterol

+6 more

DOT4 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Higher TSH groupExperimental Treatment1 Intervention

Target TSH level of 5.5-7.0 mU/L

Group II: Lower TSH GroupActive Control1 Intervention

Target TSH level of 0.5-2.0 mU/L

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levothyroxine Sodium

2019

N/A

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,055 Total Patients Enrolled

1 Trials studying Hypothyroidism

14 Patients Enrolled for Hypothyroidism

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,657 Total Patients Enrolled

1 Trials studying Hypothyroidism

14 Patients Enrolled for Hypothyroidism

Anne R. Cappola, M.D., Sc.M.Principal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree can elevated TSH levels prove detrimental to individuals?

"Our team at Power gives a rating of 3 to the Higher TSH group, signifying that this treatment has been approved and is safe."

Answered by AI

Does this experiment currently have any openings for volunteers?

"According to clinicaltrials.gov this trial is not currently seeking participants, with its first posting being made on October 1st 2023 and its last update occurring a day later. This notwithstanding, there are 18 other medical trials actively recruiting right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dosing of LT4 in Older Individuals

Anne Cappola, MD 2024. "Dosing of LT4 in Older Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073665.

All > Hypothyroidism