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Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

NCT04288115 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-11-18

Study results available
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Summary

The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.

Conditions

  • Subclinical Hypothyroidism

Interventions

DRUG

Levothyroxine

Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.

OTHER

Placebo

Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.

Sponsors & Collaborators

  • Central Arkansas Veterans Healthcare System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Spyridoula Maraka, MD MS · Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2022-10-07
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288115 on ClinicalTrials.gov