CLINICAL TRIAL

Treatment for Hypothyroidism

Recruiting · 18+ · All Sexes · North Little Rock, AR

This study is evaluating whether it is safe to stop taking levothyroxine for individuals with subclinical hypothyroidism.

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About the trial for Hypothyroidism

Eligible Conditions
Hypothyroidism · Subclinical Hypothyroidisms

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
Levothyroxine
DRUG
Control Group 2
Placebo
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Odds of Eligibility
Unknown<50%
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 6-8 weeks and 6 months.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 6-8 weeks and 6 months..
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Measurement Requirements

This trial is evaluating whether Treatment will improve 3 primary outcomes, 4 secondary outcomes, and 1 other outcome in patients with Hypothyroidism. Measurement will happen over the course of from the date that recruitment opened to the date of the last randomization, an average of 6 months.

Participants' willingness to enter the trial
FROM THE DATE THAT RECRUITMENT OPENED TO THE DATE OF THE LAST RANDOMIZATION, AN AVERAGE OF 6 MONTHS
Percent of eligible participants approached who consented to participate during the recruitment phase
Recruitment rate
FROM THE DATE THAT RECRUITMENT OPENED TO THE DATE OF THE LAST RANDOMIZATION, AN AVERAGE OF 6 MONTHS
The number of randomized participants divided by the length of the recruitment period
Completion rate
THROUGH STUDY COMPLETION, AN AVERAGE OF 6 MONTHS
Percent of randomized participants who completed the trial
Change in lipid levels
BASELINE AND 6 MONTHS.
Changes in score from baseline to 6 months. Positive change/difference is a worse outcome.
Acceptability of intervention: qualitative interview
6 MONTHS
qualitative interview to provide feedback on experiences
Change in Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) score
BASELINE, 6-8 WEEKS AND 6 MONTHS.
Changes in score from baseline to 6-8 weeks, and from baseline to 6 months. Negative change/difference is a worse outcome.
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Patient Q & A Section

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

Can hypothyroidism be cured?

Thyroid hormones are needed to maintain the body's metabolic system; however, too little or too much thyroid hormone could cause severe side-effects. Therefore, proper treatment of hypothyroidism cannot heal the body and can often result in a euthyroid condition.

Anonymous Patient Answer

How many people get hypothyroidism a year in the United States?

About 6 million Americans had [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) in 2005. The numbers of American hypothyroidism cases can be found in the section entitled “hypothyroidism”. Most cases of hypothyroidism in the United States are not discovered until later in life. Thyroid dysfunction is under-recognized in the United States. Hypothyroidism should be considered in patients over 37 years of age who have chronic diarrhea, weight gain, or tiredness, have a family history of either chronic diarrhea or hypothyroidism, or are on thyroid replacement therapy. Thyroid autoimmunity is more common in women than in men, and usually occurs in the fourth decade of life.

Anonymous Patient Answer

What are the signs of hypothyroidism?

Signs and symptoms of [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) include feeling tired, decreased energy, cold intolerance, weight gain, and feeling agitated. Some of these symptoms can be related to depression, diabetes, or menopause. A history of these symptoms indicates the possibility of hypothyroidism. A screening serum TSH is sometimes done to check for hypothyroidism. A low TSH suggests hypothyroidism. Some other laboratory tests that may be helpful in the diagnosis include a serum ESR; a CBC; thyroid profile; and, a T4 measurement. T4 measurement is a useful diagnostic test for people with symptoms suggestive of hypothyroidism, but it is not sensitive or specific.

Anonymous Patient Answer

What is hypothyroidism?

This article is based on material from the book "Handbook of Thyroid Diseases: Causes, Diagnosis and Treatment" published by Taylor and Francis, Limited (Taylor & Francis Group, Philadelphia PA) which is in the public domain in the USA"

"Odontopercha\n\nOdontopercha is a genus of flies in the family Chironomidae. It is restricted to the Americas.\n\nThere is very little data for the systematic position of this genus. Its closest morphological relatives are in the genera "Acrochordia" and "Ochrotrichia". "O.

Anonymous Patient Answer

What are common treatments for hypothyroidism?

The common options include synthetic thiamine, l-thyroxine, folic acid supplementation, and chlormadinone acetate (Medroxyprogesterone acetate). A thyroid uptake study (TUPS) and thyroid function profile (TFP) may be necessary to determine the optimal treatment. If the diagnosis is unlikely to correct, or if the clinical presentation is suggestive of other causes (e.g., Addison's disease), evaluation for Cushing's syndrome by measuring overnight and morning cortisol level and ACTH levels should be conducted. Further testing is available for more specific causes and specific management of hypothyroidism.

Anonymous Patient Answer

What causes hypothyroidism?

The major cause of [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) is thyroid autoimmunity in which the body has a natural anti-thyroid reaction and it can cause thyroid insufficiency. Autoimmune thyroid disease is usually accompanied with chronic subclinical Hashimoto's thyroiditis or with Hashimoto's thyroiditis, and it is one of the risk factors for occurrence of thyroid cancer.

Anonymous Patient Answer

Who should consider clinical trials for hypothyroidism?

Clinical trials should be conducted for people who are carefully selected and are of satisfactory nutritional status and who are diagnosed with symptoms of hypothyroidism.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

TSH testing has been developed beyond an age when it should have been abandoned. In my view however, there is one new development which could change my life; treatment with thyroid supplementation. If they can control TSH levels well enough, TPO and T3 will be found to have no additional benefit to TSH in the presence of TPO and T3 deficiency. I feel that euthyroid therapy is what’s new, and there is now enough evidence to support it in the treatment of hypothyroidism. There are now so many advantages to thyroid hormone therapy that there is no longer much reason to continue to treat patients with TSH levels above the 99th percentile with TSH testing.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

The use of treatment as a sole mode of treatment in hyperthyroidism seems inadequate. Although the effects of treatment in hyperthyroid patients are generally good, further research is needed on the treatment of hyperthyroidism.

Anonymous Patient Answer

What are the common side effects of treatment?

Side effects from treatment are very common, the first 3 months being the most common time frame. Mild to moderate side effects can easily be managed with the use of thyroid replacement therapy, for which most patients need less than 2 times as much of the medication as they did at baseline. Severe side effects are more troublesome because they typically come on suddenly and they will only be controlled by more than 2 times the amount of medication that the doctor prescribes\n

Anonymous Patient Answer

How serious can hypothyroidism be?

In children, subclinical [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) is a commonly present disorder as it is not an infrequent occurrence. This condition is more common in those who are obese, have autoimmune disease, have a family history of thyroid disease, and in those with chronic infections/inflammation of the thyroid, and those with low circulating TSH concentrations. This implies that hypothyroidism is a condition which is more common among those who have some predisposing factor. In addition to this, it is clear that this condition is more common in individuals that are not taking thyroid hormone, which may not have a significant impact on their health.

Anonymous Patient Answer

Does hypothyroidism run in families?

Genetic inheritance plays a significant role in the development of thyroid dysfunction. Families with the disease typically have more than one member affected, and a positive index case for familial hypothyroidism can be identified in 11.1% of all cases. The number of brothers and sisters in these family groups is generally lower, suggesting that a dominant mode of inheritance is likely for familial hypothyroidism.

Anonymous Patient Answer
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