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EpilepsyNCT05276271

The Effect of Levetiracetam on Lipid Profile in Children

An observational study of Epilepsy and Child, Only, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Levetiracetam is a widely prescribed antiseizure medication in epileptic children due to an estimated better safety profile and easy accessibility. There is limited and contradicting data about the effect of levetiracetam on serum lipid metabolisms, especially in epileptic children. Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Epilepsy, Child, Only, Thyroid
What is being tested?
the blood sample test results
How many people
91 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2020to 31 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

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 1 year to 18 years
  • All sexes
  • Child, Adult

Study population: A total of 37 pediatric epileptic patients (children = 16, adolescents = 21) and 54 healthy control (children = 17, adolescents = 37) were enrolled to the study. Participants admitted to the pediatric neurology outpatient clinic of Ataturk City Hospital from October 2020 to October 2021 were recruited to this observational case-control study.

Who may be able to join

  • Must be aged between 4 and 17 years
  • Must be diagnosed with epilepsy with at least two focal seizures within a year
  • Must be treated with levetiracetam monotherapy for at least 12 months.

Who cannot join

  • other medical conditions requiring continuous medication
  • abnormal thyroid function
  • progressive neurologic conditions
  • abnormal nutritional status (malnutrition, over-weight or obese)
  • epilepsy requiring poly-therapy
  • genetic diseases causing unbalanced laboratory and hormone profile

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ataturk City Hospital

    Altınoluk, Balikesi̇r, 10100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Levetiracetam Therapy on Lipid Profile in Epileptic Children

Levetiracetam is a widely prescribed antiseizure medication in epileptic children due to an estimated better safety profile and easy accessibility. There is limited and contradicting data about the effect of levetiracetam on serum lipid metabolisms, especially in epileptic children. The aim of our study was to evaluate the effect of levetiracetam therapy on lipid metabolism in euthyroid non-obese epileptic children. In this case-control study, the investigators recruited 37 epileptic children receiving levetiracetam monotherapy for at least 12 months and 54 healthy controls. All the participants were euthyroid and within normal nutritional status limits for their age. Fasting blood samples were obtained for serum thyroid-stimulating hormone (TSH), free triiodothyronine, free thyroxine, total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, Triglyceride/HDL Index, uric acid, CRP, and transaminases at the administration. The investigators would like to show if epileptic children with levetiracetam monotherapy are susceptible to lipid metabolism alterations.

Read the detailed description

A total of 37 pediatric epileptic patients (children = 16, adolescents = 21) and 54 healthy control (children = 17, adolescents = 37) were enrolled to the study. Participants admitted to the pediatric neurology outpatient clinic of Ataturk City Hospital from October 2020 to October 2021 were recruited to this observational case-control study.

The pediatric neurologist and pediatric endocrinologist evaluated all the participants' medical data to determine their medical history and physical examination. Retrospectively, all the participants' age, gender, anthropometric assessments, BMI (body weight/height2), pubertal development staging, laboratory workup (thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol (TC), aspartate aminotransferase (AST), alanine aminotransferase (ALT), uric acid, CRP) noted from the medical records. Height and weight measurements of the participants were made with a digital Harpenden stadiometer by the same person.

Seizure and epilepsy types of patients were categorized according to recommendations of the International League Against Epilepsy, 2017.

The degree of seizure control was categorized 'controlled' if they were seizure-free for ≥1 year, 'partially controlled' if the seizures' intervals were longer than seven days but shorter than 30 days, and 'uncontrolled' if the seizures occurred several times a day or at intervals shorter than seven days.

The Puberty Development Scale categorized in boys with testicular volume (testicular volume measured with a prader orchidometer) greater than 4 milliliters were considered pubertal. And for girls with breast development at Tanner stage 2 (breast development with an elevation of breast and papilla; enlargement of the areola) and above were considered pubertal.

All participants were established 'euthyroid' by evaluating TSH (mIU/L), fT3 (pmol/L), fT4(pmol/L). For participants aged 4-11.9 years, normal thyroid hormone levels were 0.2- 3.0 mIU/L for TSH, 4.6-8.2 pmol/L for fT3, and 13.8-35.3 pmol/L for fT4.For participants aged older than 11.9 years, published thyroid hormone values of Campbell et al. were used to determine normal thyroid hormone levels23. The physical examinations, blood tests (TSH, fT3, fT4, TG, HDL, LDL, total cholesterol, AST, ALT, uric acid, CRP) for each enrolled patient and control subject were obtained the time after overnight fasting (at least 10 hours) at the outpatient clinic's admission. Published lipid levels of the National Cholesterol Education Program guidelines were used for all participants 24. The TG/HDL index was calculated as the ratio of TG (mg/dL) to HDL (mg/dL) value.

The informed consent form was obtained from parents of all the children and healthy controls. The regional Ethics Committee approved the current study (2021/186-08/09/21). Statistical Analysis Statistical analyses were performed using the SPSS software version 25.0 (SPSS Statistics for Windows, 2017). The sample size was calculated by using the statistical software (G*Power version 3). The variables were investigated using visual (histogram, probability plots) and analytical methods (Kolmogorov-Smirnov) to determine whether they are normally distributed. Descriptive analyses were presented (using frequencies for ordinal variables) and using mean and standard deviation. Continuous variables were compared among the two groups by using an independent t-test. If the variable did not have a normal distribution, the Mann-Whitney U test was applied for the groups. A Chi-Square test was used to examine the association between categorical variables. A 5% type- I error level was used to infer statistical significance.

Being tested
the blood sample test results
Keywords
Child, Epilepsy, Thyroid Hormones, Lipids
Medical subject headings
Epilepsy, Thyroid Diseases, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the blood sample test resultsDiagnostic test

    Also called retrospectively collect the blood sample test results

    Retrospectively the fasting blood samples results were obtained for serum thyroid-stimulating hormone (TSH), free triiodothyronine, free thyroxine, total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, Triglyceride/HDL Index, uric acid, CRP, and transaminases at the administration.

Study groups in NCT05276271
Study groupRoleWhat they receive
epileptic childrenepileptic children who had been diagnosed with epilepsy with at least two focal seizures within a year, and treated with levetiracetam monotherapy for at least 12 months
Receives: Diagnostic Test: the blood sample test results
healthy controlshealthy controls who was without an exposure to levetiracetam
Receives: Diagnostic Test: the blood sample test results

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the effect of levetiracetam therapy on lipid profile

    Lipid profile of the epileptic children who had been receiving levetiracetam monotherapy would be compared with the healthy controls

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start1 Oct 2020
  3. Primary completion1 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05276271
Sponsor's protocol ID
2021/186
Status last verified
Mar 2022
First submitted
19 Feb 2022
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to the informed consent form which was obtained from parents of all the children and healthy controls the individual participant data wouldn't be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Child, Only, run by Ege University at 1 site in Turkey (Türkiye).

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 6 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: finished, as of the sponsor's last update on 11 Mar 2022. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the effect of levetiracetam therapy on lipid profile (time frame: 1 year). 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 11 Mar 2022.

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