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

NCT07096414 | Recruiting

• 1 other identifier: 5587
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy; Hypovitaminosis D

Keywords

Epilepsy; Vitamin D3; Hypovitaminosis D; QEEG; Brainwaves

Outcome Measures

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.

  8 weeks

Study Arms (1)

Male epileptic patients with hypovitaminosis D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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

Male epileptic patients with hypovitaminosis D

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Epilepsy; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

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

  BMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Registrar, BMU

CONTACT

+88 02 55165708; registrar@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD resident

Model Details: Experimental study (Interventional, self-controlled trial) where 15 participants will be enrolled to compare their baseline data with post interventional data.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 31, 2025
• Study Start: July 19, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)