Thyroid; Functional Disturbance study: Levothyroxine Sodium
Official title A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
ClinicalTrials.gov ID: NCT03977207
What this study is testing
What is Levothyroxine Sodium?
This is an investigational thyroid hormone supplement being studied to see if it helps people with kidney disease on dialysis. It is designed to replace the thyroid hormone that the body is not making enough of.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether levothyroxine (a thyroid hormone pill) helps people on dialysis. It looks at how it affects quality of life, heart health, and body energy.
- Who it's for
- You may be able to join if you have kidney failure and get dialysis.
- What's involved
- You would take a thyroid medicine or a pretend pill. The team will check your heart, strength, and how you feel.
- Time commitment
- The study involves regular visits to check your health over time.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orange, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.