Treatment Trial of Subclinical Hypothyroidism in Down Syndrome

• Status: Completed
• Trial end date: 2017-10-18
• Target enrollment: 0
• Participant gender: All

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 hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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