Thyroid Hormone Supplementation for Hemodialysis Patients
This study is looking at whether a thyroid hormone supplement called Levothyroxine Sodium can improve the health and well-being of people on hemodialysis who have mild hypothyroidism (elevated TSH levels). Hypothyroidism, where your thyroid gland doesn't make enough hormones, is common in people with chronic kidney disease and can affect quality of life. We want to see if Levothyroxine Sodium can improve how you feel physically. To join, you must be 18-75 years old, have been on hemodialysis for at least four weeks, and have specific elevated TSH levels with normal free thyroxine (FT4) levels. The study is currently unclear about its recruitment status and plans to enroll 336 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It will compare Levothyroxine Sodium to a placebo (an inactive pill) to see the effects.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health-related quality of life will be measured at the start of the study, then again at 12 weeks and 24 weeks.
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A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component ScoreWeek 0 (pre-trial/baseline)
We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score.
- Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component ScoreWeek 12
We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score.
- Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component ScoreWeek 24
We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score.
- Coronary Artery Calcification (CAC) - Volume ScoreWeek 0 (pre-trial/baseline)
We will assess CAC Volume Score using a 256-multidetector CT test. Volume score will be calculated by multiplying the number of voxels with calcification by the volume of each voxel for each calcified lesion, and summing individual lesion scores from the four main coronary arteries (left main, left anterior descending, circumflex, and right coronary artery).
- Coronary Artery Calcification (CAC) - Volume ScoreWeek 24
We will assess CAC Volume Score using a 256-multidetector CT test. Volume score will be calculated by multiplying the number of voxels with calcification by the volume of each voxel for each calcified lesion, and summing individual lesion scores from the four main coronary arteries (left main, left anterior descending, circumflex, and right coronary artery).