EpilepsyNCT07096414
Effect of Vitamin D3 Supplementation on Brain Waves in Male Epileptic Patients With Hypovitaminosis D
A study testing Vitamin D3 in people with Epilepsy and Hypovitaminosis D, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. . Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Epilepsy, Hypovitaminosis D
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBangladesh
- Study dates
- 19 Jul 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients suffering from absence seizure
- Certain AEDs (Sodium valproate, Ethosuximide, Oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam)
- Smoker
- Alcoholic
- Known hypersensitivity to vitamin D3
- Patients with hypertension
Show all 11Show fewer
- Patient with Thyroid disorder
- Patient with Diabetes mellitus
- Patient with Renal Disease
- Patient with liver Disease
- Patient with hypercalcemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, Shahbag, Dhaka, 1000
Dr. Sumayya Binte Abdur Razzaque, MBBS,MD Resident (Phase B), +8801731660607, dr.sumayyagmc@gmail.com
About this study
Official title: Effect of Vitamin D3 Supplementation on Brain Waves in Male Epileptic Patients With Hypovitaminosis D: A Quantitative Electroencephalogram Analysis
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:
Read more
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
Read the 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
- Being tested
- Vitamin D3
- Keywords
- Epilepsy, Vitamin D3, Hypovitaminosis D, QEEG, Brainwaves
- Medical subject headings
- Epilepsy, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start19 Jul 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental study (Interventional, self-controlled trial) where 15 participants will be enrolled to compare their baseline data with post interventional data.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumayya Binte Abdur Razzaque, Bangladesh Medical University
- Investigators
- Dr.Sumayya Binte Abdur Razzaque, MBBS, MD Resident (Phase B), Principal investigator, BMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096414
- Sponsor's protocol ID
- 5587
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Brain Waves in Male Epileptic Patients With Hypovitaminosis D: A Quantitative Electroencephalogram Analysis
- ClinicalTrials.gov ID
- NCT07096414
- Acronym / sponsor ID
- 5587
- Conditions
- Epilepsy, Hypovitaminosis D
- Keywords
- Epilepsy, Vitamin D3, Hypovitaminosis D, QEEG, Brainwaves
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental study (Interventional, self-controlled trial) where 15 participants will be enrolled to compare their baseline data with post interventional data.
| Arm | Type | Receives |
|---|---|---|
| Male epileptic patients with hypovitaminosis D | Experimental | Dietary Supplement: Vitamin D315 male epileptic patients with hypovitaminosis D will be supplemented with vitamin D orally 50,000 IU/week for 8 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- Patients suffering from absence seizure
- Certain AEDs (Sodium valproate, Ethosuximide, Oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam)
- Smoker
- Alcoholic
- Known hypersensitivity to vitamin D3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks | Dietary supplement | Male epileptic patients with hypovitaminosis D |
Primary outcome
Vitamin D3 supplementation has positive effect on brain waves in male epileptic patients with hypovitaminosis D that can be proved by quantitative electroencephalogram.
Time frame: 8 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.Sumayya Binte Abdur Razzaque, MBBS, MD Resident (Phase B) principal investigator
BMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Epilepsy and Hypovitaminosis D, run by Bangladesh Medical University at 1 site in Bangladesh.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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 Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Registrar, BMU (+88 02 55165708, registrar@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D3 supplementation has positive effect on brain waves in male epileptic patients with hypovitaminosis D that can be proved by quantitative electroencephalogram. (time frame: 8 weeks). 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 31 Jul 2025.