Status:
COMPLETED
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Down Syndrome
Subclinical Hypothyroidism
Eligibility:
All Genders
8-20 years
Phase:
NA
Brief Summary
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 h...
Detailed Description
The American Academy of Pediatrics (AAP) recommends yearly screening of thyroid studies in DS. Clinical experience suggests that thyroid stimulating hormone (TSH) concentrations in the subclinical hyp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01832753
Start Date
January 1 2013
End Date
October 18 2017
Last Update
September 6 2019
Active Locations (2)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104