What side effects are associated with this type of intervention?

Levothyroxine, a common treatment for hypothyroidism, can have several side effects, especially if dosed improperly. Potential side effects include cardiovascular issues such as atrial fibrillation and diastolic dysfunction. Over-treatment can lead to iatrogenic thyrotoxicosis, characterized by symptoms of hyperthyroidism like increased heart rate, anxiety, and weight loss. It is crucial to monitor and adjust the dosage to maintain serum TSH within the normal range to avoid these adverse effects.

What prior FDA approvals exist?

Levothyroxine, a synthetic form of the thyroid hormone thyroxine (T4), is the primary FDA-approved treatment for hypothyroidism. It is used to replace or supplement the thyroid hormone in patients with hypothyroidism, ensuring normal metabolic function. Other related drugs include liothyronine (synthetic T3) and desiccated thyroid extract, which contains both T3 and T4. These treatments aim to normalize thyroid hormone levels and alleviate symptoms associated with hypothyroidism.

What other types of research exist?

Promising alternatives to Levothyroxine for hypothyroidism treatment include: 1) Combination therapy with Levothyroxine (LT4) and Liothyronine (LT3), which some patients prefer despite inconsistent trial results. 2) Desiccated thyroid extract, which has shown patient preference in some studies. 3) Slow-release T3 preparations, which aim to provide a more physiologic hormone release pattern. These alternatives are being explored to address persistent symptoms in some patients despite normal TSH levels with Levothyroxine monotherapy.

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Hormone Therapy

Thyroid Hormone Supplementation for Hypothyroidism in Hemodialysis Patients (THYROID-HD Trial)

N/A

Recruiting

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

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

Must have

Age 18-75 years old

Be older than 18 years old

Must not have

Active treatment with thyroid hormone supplementation or anti-thyroid medications

Active receipt of dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial tests if levothyroxine, a thyroid hormone replacement, can improve quality of life and heart health in dialysis patients with slightly high TSH levels. The medication aims to balance their thyroid hormone levels. Levothyroxine is a commonly used thyroid hormone replacement therapy that has been shown to improve heart function and physical activity without significant side effects.

Who is the study for?

This trial is for people aged 18-75 on hemodialysis with mild to moderate hypothyroidism, not currently treated for thyroid issues. They must have stable heart function and no severe bone disease, weigh less than 450 lbs., and not be pregnant or planning pregnancy.

What is being tested?

The study tests if Levothyroxine improves life quality and cardiovascular health in dialysis patients compared to a placebo. It also looks at metabolic effects like changes in body fat and energy use.

What are the potential side effects?

Levothyroxine may cause symptoms like shakiness, heart palpitations, difficulty sleeping, increased appetite but weight loss, sweating more than usual, sensitivity to heat.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for my thyroid condition.

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I am currently on dialysis.

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I am currently experiencing worsening heart failure symptoms.

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I have an active cancer or a history of thyroid cancer.

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I have been diagnosed with osteoporosis.

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I have heart issues like blocked arteries or irregular heartbeat.

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I have been diagnosed with hyperthyroidism or am on medication for it.

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I have had a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Coronary Artery Calcification (CAC) - Volume Score

Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score

Secondary study objectives

Endothelial Function - Digital Thermal Monitor

Muscle Strength - Isometric Dynamometry

Physical Performance - Short Physical Performance Battery (SPPB)

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LevothyroxineExperimental Treatment1 Intervention

Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\>3.0-5.0 and 5.0-10.0mIU/L) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \>3.0-5.0mIU/L vs. 5.0-10.0mIU/L, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level. The intervention period is 24 weeks. Patients will undergo up to two subsequent dose titrations after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points. Patients whose TSH levels are higher or lower than the therapeutic TSH target of 0.5-3.0mIU/L will undergo a dose adjustment (+/- 25mcg), while those whose TSH levels are in target range will continue the prior dose.

Group II: PlaceboPlacebo Group1 Intervention

Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\>3.0-5.0 and 5.0-10.0mIU/L) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \>3.0-5.0mIU/L vs. 5.0-10.0mIU/L, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level. The intervention period is 24 weeks. Patients in the placebo arm will undergo an equivalent titration in placebo pills (as that of the experimental arm) after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levothyroxine

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Levothyroxine, a synthetic form of thyroxine (T4), is the most common treatment for hypothyroidism. It works by supplementing the deficient thyroid hormone, which is then converted to the active form triiodothyronine (T3) in the body. This hormone replacement helps normalize thyroid hormone levels, alleviating symptoms like fatigue, weight gain, and depression, and restoring normal metabolic activity. For hypothyroidism patients, this treatment is essential for managing their condition and improving their quality of life.

Benefits and Harms of Levothyroxine/L-Triiodothyronine Versus Levothyroxine Monotherapy for Adult Patients with Hypothyroidism: Systematic Review and Meta-Analysis.Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.A systematic review of randomized controlled trials for management of persistent post-treatment fatigue in thyroid cancer survivors.