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Could a thyroid pill boost heart health in dialysis patients?

NCT ID NCT03977207

Disease control Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving a thyroid hormone supplement (levothyroxine) to dialysis patients with mild hypothyroidism can improve their quality of life and heart health. About 336 adults on hemodialysis will receive either the hormone or a placebo for up to two years. The goal is to see if this common treatment actually helps this specific group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levothyroxine (thyroid hormone supplement)
What this could lead to
If it works, this could point toward a safe way to improve quality of life and reduce heart disease risk in dialysis patients with mild hypothyroidism.
What could go wrong
This is a mid-sized trial, but the condition is mild and the benefits may be small. There is also a risk of overtreatment or side effects from thyroid hormone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 336 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-75 years old * Received hemodialysis at least four weeks * Have two consecutive thyrotropin (TSH) levels \>3.0-10.0mIU/L during the screening period * Have normal free thyroxine (FT4) levels * Have ability to provide written informed consent Exclusion Criteria: * Active treatment with thyroid hormone supplementation or anti-thyroid medications * Active receipt of dialysis * Prior kidney transplantation * Life expectancy less than six months * Active malignancy or prior thyroid malignancy * Active pregnancy or planning a pregnancy * Active coronary ischemia or atrial fibrillation (evaluated by EKG) * Active congestive heart failure exacerbation * Osteoporosis * Weight in excess of 450 lbs. * Hyperthyroidism as determined by TSH \<0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis

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Conditions

The condition(s) this trial relates to.

end stage renal failure hypothyroidism thyroid gland disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemodialysis Hypothyroidism Thyroid; functional disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

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