Treatment Trial of Subclinical Hypothyroidism in Down Syndrome
Completed · Not applicable
Conditions studied: Down Syndrome, Subclinical Hypothyroidism
In brief
The purpose of this research study is to learn about the effects of treating subclinical hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.
Key facts
- Study ID
- NCT01832753
- Run by
- Children's Hospital of Philadelphia
- People needed
- 12
- Starts
- 2013-01-01
- Expected to finish
- 2017-10-18
- Last updated by the study team
- 2019-09-06
Who can join
Age: 8 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females, ages 8 - 20 years
- Diagnosis of Down syndrome
- Subclinical hypothyroidism: TSH level between 5 - 10 mIU/L, normal T4
- Parental/guardian permission (informed consent) and if appropriate, child assent
- Females who are at least 11 years of age or who are menarchal must have a negative urine/serum pregnancy test
- Committed to adherence to levothyroxine treatment and study completion
You may not qualify if…
- Pregnancy
- Type 1/Type 2 diabetes
- Chronic medical conditions or medication use that can affect growth, nutrition, blood glucose, insulin secretion, or thyroid function (such as lithium or certain seizure medications)
- Current use of levothyroxine or anti-thyroid hormone
- Cyanotic congenital heart disease, or pulmonary hypertension (as described by last echo report in subjects with CHD), or congenital heart disease considered medically unstable by the study cardiologists
Where it is running
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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