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Treatment Trial of Subclinical Hypothyroidism in Down Syndrome

NCT01832753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-09-06

Study results available
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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.

Conditions

  • Down Syndrome
  • Subclinical Hypothyroidism

Interventions

DRUG

Levothyroxine

Sponsors & Collaborators

Principal Investigators

  • Andrea Kelly, MD, MSCE · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-10-18
Completion
2017-10-18

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832753 on ClinicalTrials.gov