Effect of Vitamin D3 Supplementation on Brain Waves in Male Epileptic Patients With Hypovitaminosis D

NCT ID: NCT07096414

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-19
• Study Completion Date: 2025-10-31

Brief Summary

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

Detailed Description

This experimental study (self-controlled trial) will be conducted by the Department of Physiology, Bangladesh Medical University, Shahbag, Dhaka from March 2025-February 2026. For this study, a total number of 15 male patients with Epilepsy (age 20-40 years) will be enrolled as study participants according to selection criteria (Diagnosed male patients with Epilepsy by neurologist from the Out Patient Department of Department of Neurology by taking proper history of at least two unprovoked (or reflex) seizures occurring > 24 hours apart, from patients and eye witnesses, having Hypovitaminosis D (<30 ng/ml), Age: 20-40 years, BMI : 20 - 24 kg/m², On antiepileptic medication for 6 months to 2 years (enzyme inducing AEDs, e.g. Carbamazepine, Phenytoin, Phenobarbital), Without any medication that affect central nervous system other than antiepileptic drugs (Antidepressants, Antipsychotic, Anxiolytic, Anesthetic drugs), Apparently normal physical health ) At first baseline serum 25(OH) D level will be measured & baseline QEEG will be recorded. After that the participants will be supplemented vitamin D3 orally (50,000IU/week) for 8 weeks. After completion of 8 weeks, serum 25(OH) D level will be measured again & QEEG will be recorded.

To analyze brain electrical activities, the band power of alpha, beta, theta, and Delta brainwaves will be measured using an EEG Data gathering Device, the EEG Traveler BrainTech 32+ CMEEG-01 from India. The BT40 analysis software will be used to perform power spectral analysis of the EEG data. Mean ± SD will be used to express the data.

For statistical analysis, to compare the mean values between the pre intervention and post intervention sessions, paired t test will be done.The P value of ≤0.05 will be accepted as statistically significant. SPSS for Windows (version 25) will be used for the statistical analysis.

The findings of this study are expected to provide quantitative evidence regarding the neurophysiological effects of vitamin D3 supplementation in male epileptic patients with hypovitaminosis D.Also it could help people with epilepsy to lead healthier, more productive lives.

Conditions

Epilepsy; Hypovitaminosis D

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Male epileptic patients with hypovitaminosis D

15 male epileptic patients with hypovitaminosis D will be supplemented with vitamin D orally 50,000 IU/week for 8 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks

Interventions

Vitamin D3

Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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)
• Without any medication that affect central nervous system other than antiepileptic drugs (Antidepressants, Antipsychotic, Anxiolytic, Anesthetic drugs)
• Apparently normal physical health

Exclusion Criteria

• Patients suffering from absence seizure
• Certain AEDs (Sodium valproate, Ethosuximide, Oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam)
• Smoker
• Alcoholic
• Known hypersensitivity to vitamin D3
• Patients with hypertension
• Patient with Thyroid disorder
• Patient with Diabetes mellitus
• Patient with Renal Disease
• Patient with liver Disease
• Patient with hypercalcemia

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bangladesh Medical University

OTHER

Sponsor Role: lead

Responsible Party

Sumayya Binte Abdur Razzaque

MD resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.Sumayya Binte Abdur Razzaque, MBBS, MD Resident (Phase B)

Role: PRINCIPAL_INVESTIGATOR

BMU

Locations

Bangladesh Medical University

Dhaka, Shahbag, Dhaka, Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Registrar, BMU

Role: CONTACT

registrar@bsmmu.edu.bd

+88 02 55165708

Facility Contacts

Dr. Sumayya Binte Abdur Razzaque, MBBS,MD Resident (Phase B)

Role: primary

dr.sumayyagmc@gmail.com

+8801731660607

Other Identifiers

5587

Identifier Type: -

Identifier Source: org_study_id