In addition to the Metabolic Health study, we are also conducting the Down Syndrome Thyroid Treatment Study. This is a separate study investigating treatment of subclinical hypothyroidism (SCH) in children and adolescents with Down syndrome. We are looking for 40 children and adolescents between the ages of 8-20 with both Down syndrome and SCH to participate. This study is also recruiting from both the Children's Hospital of Philadelphia (CHOP) and Children's National Medical Center (CNMC), and study visits can take place at either CHOP or CNMC.
Subclinical hypothyroidism means that your body's level of thyroid stimulating hormone (TSH) is above normal, but you likely do not have symptoms of hypothyroidism. Studies have shown that adults with SCH are at increased risk for developing type 2 diabetes and heart problems. SCH is common in DS, but it is unknown whether treatment of SCH in Down Syndrome is beneficial.
Through this study, we hope to learn more about whether treating SCH will result in any changes to the cardiometabolic health of children and adolescents with DS. This information may help medical providers decide how to manage SCH in children and adolescents with DS.
If you agree to take part, your participation may last for up to 18 months and will involve 1 research visit every 6 months (up to 4 research visits) at either CNMC's or CHOP's main hospital. The study also involves 3 blood draw visits that can be done at the main hospital of either site, or at a CHOP or CNMC satellite location that is convenient to you.
Your child will be asked to take medication for one year. During the first 6 months, your child will receive either levothyroxine (an active medication), or a placebo. In the final 6 months, all participants will receive levothyroixine.
You and your child will be compensated for each research visit and each blood draw visit that you complete.
The following procedures will be completed during each research visit at either CHOP or CNMC Main:
You may need to have bloodwork done between visits to the main hospital to assess your thyroid hormone levels. These can be done at a CHOP or CNMC affiliated lab closer to you.
After each research visit:
If you would like more information, please take a look at our study flyer! You can download a PDF of it by clicking on the picture below:
*Many factors are considered when determining an individual's eligibility, so while the above should serve as a general guideline, please contact the study team to review your child's eligibility in further detail and determine whether he or she is able to participate in the study.