LevothyroxineNCT07393165
Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
A study testing L-thyroxine in people with Levothyroxine and Cardiac Function, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Levothyroxine, Cardiac Function, Children
- What is being tested?
- L-thyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Hyperlipidemia
- Diabetes
- Infectious diseases
- Respiratory diseases
- Malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Zeinab E Elshareef, MBBCH, 00201001700194, zeinabibraheem26@gmail.com
Doaa M EL Amrousy, MD
About this study
Official title: The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.
Read the detailed description
Subclinical hypothyroidism (SH) is a branch of hypothyroidism which is characterized by increased thyroid stimulating hormone (TSH) and normal thyroxine (T4).
Inadequate serum thyroid hormone levels impair cardiac function and may result in multiple cardiovascular risk factors, such as endothelial dysfunction, increased intima-media thickness, increased vascular resistance, and pericardial effusion.
- Conditions
- Levothyroxine, Cardiac Function, Children, Subclinical Hypothyroidism
- Being tested
- L-thyroxine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-thyroxineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: L-thyroxine |
| No treatment group | No intervention | Children with subclinical hypothyroidism who will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-procedure
Secondary outcomes (1)
Assessment of left ventricle fractional shortening
Left ventricle fractional shortening (LV FS) will be measured. where: LV FS= LVEDD-LVESD/LVEDD X 100%.
LVEDD=left ventricular end-diastolic dimension. LVESD=left ventricular end-systolic dimension.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start24 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LevothyroxineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Ebraheem Amin Elshareef, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393165
- Sponsor's protocol ID
- 36264MS959/5/25
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
- ClinicalTrials.gov ID
- NCT07393165
- Acronym / sponsor ID
- 36264MS959/5/25
- Conditions
- Levothyroxine, Cardiac Function, Children, Subclinical Hypothyroidism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of the treatment with levothyroxine on cardiac function in children with subclinical hypothyroidism.
Detailed description
Subclinical hypothyroidism (SH) is a branch of hypothyroidism which is characterized by increased thyroid stimulating hormone (TSH) and normal thyroxine (T4).
Inadequate serum thyroid hormone levels impair cardiac function and may result in multiple cardiovascular risk factors, such as endothelial dysfunction, increased intima-media thickness, increased vascular resistance, and pericardial effusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: L-thyroxineChildren 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. |
| No treatment group | No intervention | –Children with subclinical hypothyroidism who will receive no treatment. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Overweight and obesity
- Hypertension
- Previous use of levothyroxine, antiepileptic drugs, or cardiac drugs within the last 6 months.
- Arrhythmia.
- Congenital or acquired heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-thyroxineChildren 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 | Treatment group |
Primary outcome
Assessment of left ventricle systolic function
Time frame: 3 months post-procedure
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.
1 secondary outcome
Assessment of left ventricle fractional shortening
Time frame: 3 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Levothyroxine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-thyroxine in people with Levothyroxine and Cardiac Function, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeinab E Elshareef, MBBCH (00201001700194, zeinabibraheem26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of left ventricle systolic function (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.