Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05276271 |
| Other study ID # |
2021/186 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
October 31, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Ege University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
