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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

THYROID-HD Trial Summary

This trial will study whether levothyroxine, a medication frequently prescribed for chronic kidney disease patients, is effective and safe for this population. The study will investigate whether levothyroxine improves patient-centered and cardiovascular outcomes in dialysis patients, and if thyroid hormone replacement exerts classic metabolic effects in this population.

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.Check my eligibility

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.See study design

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.

THYROID-HD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 75 years old.

THYROID-HD Trial 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

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

Primary outcome measures

Coronary Artery Calcification (CAC) - Volume Score

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

Secondary outcome measures

Endothelial Function - Digital Thermal Monitor

Muscle Strength - Isometric Dynamometry

Physical Performance - Short Physical Performance Battery (SPPB)

+5 more

THYROID-HD 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,707 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,159 Total Patients Enrolled

4 Trials studying Hypothyroidism

2,533 Patients Enrolled for Hypothyroidism

Media Library

Levothyroxine Sodium (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03977207 — N/A

Hypothyroidism Research Study Groups: Levothyroxine, Placebo

Hypothyroidism Clinical Trial 2023: Levothyroxine Sodium Highlights & Side Effects. Trial Name: NCT03977207 — N/A

Levothyroxine Sodium (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03977207 — N/A

Frequently Asked Questions

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

Is there an ongoing recruitment period for this research study?

"Affirmative. According to the records hosted on clinicaltrials.gov, registration for this medical trial is still open; it was first posted on July 1st 2019 and updated as recently as December 16th 2020. The study needs 336 participants from a single location."

Answered by AI

Does this clinical trial include geriatric participants?

"According to the requirements, individuals aged between 18 and 75 are eligible for this trial. In addition, 27 trials exist that serve minors while 223 other studies cater to those over 65 years old."

Answered by AI

Under what circumstances is Levothyroxine Sodium typically prescribed?

"Levothyroxine Sodium is typically administered to combat the growth of malignant tumors. Additionally, this medication can be used for euthyroid goitre, obesity and hypothyroidism management."

Answered by AI

Could I possibly become part of this clinical study?

"Applicants to this medical trial should present with hypothyroidism and be between 18-75 years old. An estimated 336 participants will be selected for inclusion in the study."

Answered by AI

What is the approximate size of the cohort participating in this trial?

"Affirmative, the current information hosted on clinicaltrials.gov shows that this research is currently enrolling participants, beginning with its posting date of July 1st 2019 and most recently updated on December 16th 2020. The trial hopes to collect data from 336 individuals at a single site."

Answered by AI

What objectives has this medical trial set out to accomplish?

"This 24-week clinical trial is tasked with calculating the Coronary Artery Calcification (CAC) - Volume Score as its primary objective. Secondary goals include evaluating Endothelial Function through Digital Thermal Monitor tests, measuring Resting Energy Expenditure via Indirect Calorimetry, and Total Body Fat Percentage using Dual Energy X-Ray absorptiometry."

Answered by AI