Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism

NCT07393165 | Recruiting

• 1 other identifier: 36264MS959/5/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.

Conditions

Levothyroxine; Cardiac Function; Children; Subclinical Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Assessment of left ventricle systolic function

  Left ventricle systolic function will be measured using left ventricle (LV) ejection fraction (LV EF%) where: (LV EF%) = (LVEDD)³ - (LVESD) / (LVEDD)³×100% LVEDD=left ventricular end-diastolic dimension. LVESD=left ventricular end-systolic dimension. LVFS=LV fractional shortening.

  3 months post-procedure

Secondary Outcomes (1)

• Assessment of left ventricle fractional shortening

  3 months post-procedure

Study Arms (2)

Treatment group

EXPERIMENTAL

Children with subclinical hypothyroidism who will receive L-thyroxine treatment in a dose of 2μg/kg/d (the smallest dose can be given) and the dose will be titrated every 4 weeks until a normal thyroid-stimulating hormone (TSH) level is maintained.

Drug: L-thyroxine

No treatment group

NO INTERVENTION

Children with subclinical hypothyroidism who will receive no treatment.

Interventions

L-thyroxine DRUG

Children with subclinical hypothyroidism who will receive L-thyroxine treatment in a dose of 2μg/kg/d (the smallest dose can be given) and the dose will be titrated every 4 weeks until a normal thyroid-stimulating hormone (TSH) level is maintained.

Treatment group

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 4 to 15 years.
• Both sexes.
• Patients with stable elevated thyroid-stimulating hormone (TSH) ≥ 4.5 mIU/L with normal free T4 and ft3 in different measurement 4 - 6 weeks apart.

You may not qualify if:

• Overweight and obesity
• Hypertension
• Previous use of levothyroxine, antiepileptic drugs, or cardiac drugs within the last 6 months.
• Arrhythmia.
• Congenital or acquired heart disease
• Liver or kidney disease
• Hyperlipidemia
• Diabetes
• Infectious diseases
• Respiratory diseases
• Malignancies

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

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

Zeinab E Elshareef, MBBCH

CONTACT

00201001700194; zeinabibraheem26@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Pediatrics, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: May 24, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)