Effect of Vitamin D3 Supplementation on Brain Waves in Male Epileptic Patients With Hypovitaminosis D
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-40
SponsorBangladesh Medical University
About this trial
This is an experimental study (interventional self-controlled trial, pretest-post test design). The goal of this clinical trial is to evaluate the effect of vitamin D3 supplementation on quantitative EEG in male epileptic patients with hypovitaminosis D.
. The main question it aims to answer is:
Vitamin D3 supplementation has effect on brain waves in male epileptic patients with hypovitaminosis D.
Researcher will compare the effect of Vitamin D3 supplementation on brain waves in male epileptic patients with hypovitaminosis D with their pre-intervention (baseline) condition on brain waves to assess whether there will be any improvement of brain electrical activity by quantitative electroencephalogram (QEEG).
Participants will:
Take Vitamin D3 orally for 8 weeks (50,000IU/week) Visit the medical university after 8 weeks for evaluation of serum 25 (OH) D level and quantitative electroencephalogram (QEEG) Must bring the empty strips of Vitamin D supplement with them during their visit
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed male patients with Epilepsy by neurologist from the Out Patient Department of Department of Neurology, BMU by taking proper history of at least two unprovoked (or reflex) seizures occurring > 24 hours apart, from patients and eye witnesses.
Hypovitaminosis D (<30 ng/ml)
BMI : 20 - 24 kg/m²
On antiepileptic medication for 6 months to 2 years (enzyme inducing AEDs, e.g. Carbamazepine, Phenytoin, Phenobarbital)
Disqualifiers
Patients suffering from absence seizure
Certain AEDs (Sodium valproate, Ethosuximide, Oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam)
Smoker
Alcoholic
Trial design
Design model
Single group
Treatments tested in this trial
Vitamin D3
Dietary supplementAdministration of vitamin D3 capsule 50,000 IU/week for 8 weeks
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Male epileptic patients with hypovitaminosis DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Vitamin D3 supplementation has positive effect on brain waves in male epileptic patients with hypovitaminosis D that can be proved by quantitative electroencephalogram.
15 male epileptic patients with serum 25(OH)D level less than normal, will be supplemented with vitamin D capsule 50,000 IU/WEEK for 8 weeks. That may have an effect on brain electrical activity (altering the power of different frequency brain waves) and ultimately change seizure frequency which can be assessed by quantitative EEG using Fast Fourier Transform method.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov