Can Levothyroxine Treatment Reduce the Development of Cardio-metabolic Disorder in Subclinical Hypothyroidism?

NCT04178928 | Unknown Phase 1

• 1 other identifier: Sub clinical hypothyroidism
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

2\. Aim/ Objectives The aim of this study is to evaluate the clinical, laboratory and echocardiographic findings in children with SCH. To investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.

Conditions

Subclinical hypothyroïdism

Outcome Measures

Primary Outcomes (1)

• : Normalization of TSH.

  Normalization of TSH by receive L-T4 treatment at a dose 1 µg/kg/day for 12 weeks. And the dose will be titrated every 4 weeks then check differences in results between baseline assessment and12 weeks after intervention.

  12 week

Study Arms (2)

group A

ACTIVE COMPARATOR

patiWill receive L-T4 treatment at a dose 1 µg/kg/day for 12 weeks. And the dose will be titrated every 4 weeksents with SCH will be subjected to clinical, laboratory and imaging assessment and

Drug: Levothyroxine

Group B

NO INTERVENTION

.pWill not receive treatment.atients with SCH will be subjected to clinical, laboratory and imaging assessment and

Interventions

Levothyroxine DRUG

investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.

group A

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Patients aged from 5-15 years diagnosed with SH (patients with elevated TSH and normal Ft4 on two different measurements 4-6 weeks apart).

You may not qualify if:

• \. Patients with acute or chronic disorders (anemia, infection, diabetes mellitus, malignancy, liver and renal disorder).
• \. Patients with a history of medication that affect thyroid function tests as glucocorticoids, dopamine or dobutamine, amiodarone, lithium, interferons, alemtuzumab.
• \. Patients with BMI\>95 percentile.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Nashwa MOhamed Abd elwahab, MSCof pediatrics

CONTACT

01061487888; nashwa.abotaleb@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD candidate

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-11