N/A N=12 Randomized Double-blind Treatment

Treatment Trial of Subclinical Hypothyroidism in Down Syndrome

Down Syndrome · Subclinical Hypothyroidism

Bottom Line

View on ClinicalTrials.gov: NCT01832753 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Change in Lipid Panel From Baseline at 6, 12 and 18 Months. — 160; 170; 163; 172 mg/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Levothyroxine (Drug)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Lipid Panel From Baseline at 6, 12 and 18 Months.	160; 170; 163; 172; 156.5; 226	—
SECONDARY Change in Quality of Life From Baseline at 6, 12 and 18 Months.	70.65; 69.02; 52.17; 66.305; 61.41; 50	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01832753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.