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Thyroid Hormone Replacement

Levothyroxine group ("sham discontinuation") for Hypothyroidism

Phase 4
Waitlist Available
Led By Spyridoula Maraka, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the time from first consent signed to last consent signed. march 2021 to april 2022. 13 months.
Awards & highlights

Study Summary

This trial will study whether it is safe to stop taking levothyroxine for people with subclinical hypothyroidism, and if doing so will affect their quality of life.

Eligible Conditions
  • Hypothyroidism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time from first consent signed to last consent signed. march 2021 to april 2022. 13 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the time from first consent signed to last consent signed. march 2021 to april 2022. 13 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
Completion Rate
Participants' Willingness to Enter the Trial
Recruitment Rate
Secondary outcome measures
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
Lipid Levels
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score
+1 more
Other outcome measures
Acceptability of intervention: qualitative interview

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Levothyroxine group ("sham discontinuation")Active Control1 Intervention
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
Group II: Placebo group ("real discontinuation")Placebo Group1 Intervention
Stop the current dose of levothyroxine and take study placebo

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,401 Total Patients Enrolled
Central Arkansas Veterans Healthcare SystemFED
23 Previous Clinical Trials
3,488 Total Patients Enrolled
Spyridoula Maraka, MD MSPrincipal InvestigatorCentral Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Frequently Asked Questions

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

To what extent does the Levothyroxine group present a potential hazard for individuals?

"Given that Levothyroxine group ("sham discontinuation") has received approval from the FDA, our team at Power rated its safety a 3 out of possible 3."

Answered by AI

What medical purpose does Levothyroxine group ("sham discontinuation") typically serve?

"Levothyroxine group ("sham discontinuation") is a common therapeutic intervention for treating malignant neoplasms, euthyroid goitre, obesity, and hypothyroidism."

Answered by AI

Does this investigation currently admit enrollees?

"The clinical trial under discussion is not presently seeking participants. It was initially posted on March 2nd 2021, and its last edit occurred on June 22nd 2022. If you are looking for alternative studies, there are presently 13 trials searching for patients with hypothyroidism and 10 more trials actively recruiting members of the Levothyroxine group (“sham discontinuation”)."

Answered by AI

Are elderly persons precluded from participating in this trial?

"This research program necessitates that prospective participants are aged between 18 and 89, with a distinct 5 studies for minors and 20 for seniors."

Answered by AI

How many participants are eligible to receive the treatments offered in this experiment?

"This trial is not currently enrolling and the listing was last edited on June 22nd, 2022. If you are looking for alternative trials related to hypothyroidism or Levothyroxine group ("sham discontinuation"), there are 13 and 10 active studies respectively which may be of interest."

Answered by AI

What are the desired outcomes of this clinical experiment?

"This medical trial's principal aim is to measure completion rates over a 6-month period from the start of recruitment. Additional objectives include an evaluation of participants' tiredness and hypothyroid symptoms scores compared with baseline values at 6 weeks, as well as changes in lipid levels after 6 months; negative differences for former two parameters reflect worse outcomes whereas positive discrepancies signify poorer results for the latter."

Answered by AI

To whom is enrollment in this research project open?

"This medical trial seeks to recruit 50 participants with hypothyroidism, aged between 18 and 89. Most notably, potential candidates must have been a Veteran diagnosed with SCH in the time period of January 1st 2009 and December 31st 2019 at Central Arkansas Veterans Healthcare System (CAVHS)."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~13 spots leftby Apr 2025