EpilepsyNCT07085598
Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D
A study testing Vitamin D in people with Epilepsy, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to see the effect of vitamin D3 supplementation on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D that weather vitamin D improves heart rate variability or not. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Vitamin D
- 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
- 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 OPD of Department of Neurology by taking proper history of at least two unprovoked (or reflex) seizures occuring > 24 hours apart, from patients and eye witnesses.
- Having hypovitaminosis D (serum vitamin D3 level <30 ng/ml)
- Age: 20-40 years.
- Sex: Male
- BMI : 18.5-24.9 kg/m2
- Taking antiepileptic drug for 6 months to 2 years ( Enzyme inducer AEDs, e.g. Carbamazepine, Phenytoin, Phenobarbital)
- Without medication that affect central nervous system other than antiepileptic drugs (AEDs).
Who cannot join
- • Epileptic patients taking Sodium valproate, oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam.
- Patient having absence seizure
- Alcoholic
- Smoker
- Patients taking following drugs will be excluded-
- Anti-diabetic drugs
Show all 25Show fewer
- Antioxidant vitamin supplements
- Antihypertensive drug
- Anti-arrhythmic drug
- Lipid lowering medications
- Sedatives
- Patients having known hypersensitivity to vitamin D3
- All patients with the history of or currently suffering from following diseases \& condition will be excluded-
- Cardiovascular disorders (Myocardial infarction, coronary heart disease, cardiac arrhythmia, CCF)
- Other neurological disorders (Migraine, stroke)
- Respiratory disorders (Bronchial asthma, COPD)
- Renal insufficiency (S. Creatinine > 1.5 mg/dl, Acute or chronic kidney disease)
- Endocrine disease (Diabetes mellitus, Thyroid disorders- hypothyroidism, hyperthyroidism)
- Arthritis (rheumatoid arthritis)
- Liver diseases
- Neoplastic disease
- Psychiatric disorder (schizophrenia, bipolar disorder)
- Current use of iron, zinc, calcium, magnesium and multivitamin supplementation
- Already performing yoga or breathing exercise
- Patients 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, 1000
Dr. Samikha Sarker, MBBS, MD Resident (Phase B), +88 01774441584, samiksha.damc@gmail.com
Dr. Samikha Sarker, MBBS, MD Resident (Phase B)
About this study
The goal of this clinical trial is to see the effect of vitamin D3 supplementation on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D that weather vitamin D improves heart rate variability or not. The main questions it aims to answer are:
- Does vitamin D improves cardiac autonomic tone in male epileptic patients?
- Does vitamin D improves heart rate variability in male epileptic patients?
Read more
It is a self control trial. Participants will:
- undergo through baseline HRV testing
- start to take vitamin D3 50000 IU once in a week for 8 weeks
- visit the university after 8 weeks for post interventional HRV testing . Researcher will compare the pre test and post test value of HRV testing.
Read the detailed description
In epilepsy, there is a shifting of autonomic balance toward sympathetic dominance \& heart rate variability (HRV) is reduced which can be detected by interictal heart rate variability (HRV) testing. Patients treated with anti-epileptic drugs (AEDs) are suffered from one of its major adverse effects of vitamin D3 deficiency or hypovitaminosis D due to enzyme inducing effect of AEDs. Vitamin D3 is a neuroprotective hormone that modulates autonomic balance and regulates sympathetic and parasympathetic nervous systems. Vitamin D3 deficiency is also associated with the risk of reduced HRV. Administration of vitamin D3 in vitamin D3 deficient epileptic patients may improve their cardiac autonomic nerve function that can be interpreted by HRV.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
15 male epileptic patients with hypovitaminosis D will be enrolled. They will be supplemented with Vitamin D orally 50,000 IU/week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 15 male epileptic patients with hypovitaminosis D | Experimental | 15 male epileptic patients with hypovitaminosis D will be enrolled. They will be supplemented with Vitamin D orally 50,000 IU/week for 8 weeks Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D.
In epilepsy, cardiac autonomic nerve function is altered which can be measured by heart rate variability test(HRV). HRV is reduced in epilepsy. Vitamin D3 supplementation in patients with epilepsy will improve their cardiac autonomic nerve function which can be detected by measuring various parameters of HRV test such as SDRR, LF(Low frequency).
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 posted25 Jul 2025
- Study startJul 2025 (estimated)
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 15 epileptic patients with hypovitaminosis D will be enrolled
- 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, Samikha Sarker, Bangladesh Medical University
- Investigators
- Dr. Samikha Sarker, MBBS, MD Resident (Phase B), Principal investigator, BMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085598
- Sponsor's protocol ID
- 5592
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teagarden DL, Meador KJ, Loring DW. Low vitamin D levels are common in patients with epilepsy. Epilepsy Res. 2014 Oct;108(8):1352-6. doi: 10.1016/j.eplepsyres.2014.06.008. Epub 2014 Jul 6.
PubMed 25060996
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D
- ClinicalTrials.gov ID
- NCT07085598
- Acronym / sponsor ID
- 5592
- Conditions
- Epilepsy
- Keywords
- Vitamin D3, Hypovitaminosis D, HRV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 25 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.
The goal of this clinical trial is to see the effect of vitamin D3 supplementation on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D that weather vitamin D improves heart rate variability or not. The main questions it aims to answer are:
- Does vitamin D improves cardiac autonomic tone in male epileptic patients?
- Does vitamin D improves heart rate variability in male epileptic patients?
It is a self control trial. Participants will:
- undergo through baseline HRV testing
- start to take vitamin D3 50000 IU once in a week for 8 weeks
- visit the university after 8 weeks for post interventional HRV testing . Researcher will compare the pre test and post test value of HRV testing.
Detailed description
In epilepsy, there is a shifting of autonomic balance toward sympathetic dominance \& heart rate variability (HRV) is reduced which can be detected by interictal heart rate variability (HRV) testing. Patients treated with anti-epileptic drugs (AEDs) are suffered from one of its major adverse effects of vitamin D3 deficiency or hypovitaminosis D due to enzyme inducing effect of AEDs. Vitamin D3 is a neuroprotective hormone that modulates autonomic balance and regulates sympathetic and parasympathetic nervous systems. Vitamin D3 deficiency is also associated with the risk of reduced HRV. Administration of vitamin D3 in vitamin D3 deficient epileptic patients may improve their cardiac autonomic nerve function that can be interpreted by HRV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 epileptic patients with hypovitaminosis D will be enrolled
| Arm | Type | Receives |
|---|---|---|
| 15 male epileptic patients with hypovitaminosis D | Experimental | Dietary Supplement: Vitamin D15 male epileptic patients with hypovitaminosis D will be enrolled. They 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 (7 listed)
- • Diagnosed male patients with Epilepsy by neurologist from the OPD of Department of Neurology by taking proper history of at least two unprovoked (or reflex) seizures occuring > 24 hours apart, from patients and eye witnesses.
Key exclusion criteria (25 listed)
- • Epileptic patients taking Sodium valproate, oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam.
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 D15 male epileptic patients with hypovitaminosis D will be enrolled. They will be supplemented with Vitamin D orally 50,000 IU/week for 8 weeks | Dietary supplement | 15 male epileptic patients with hypovitaminosis D |
Primary outcome
Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D.
Time frame: 8 weeks
In epilepsy, cardiac autonomic nerve function is altered which can be measured by heart rate variability test(HRV). HRV is reduced in epilepsy. Vitamin D3 supplementation in patients with epilepsy will improve their cardiac autonomic nerve function which can be detected by measuring various parameters of HRV test such as SDRR, LF(Low frequency).
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 25 Jul 2025.
- Background: PubMed 25060996Teagarden DL, Meador KJ, Loring DW. Low vitamin D levels are common in patients with epilepsy. Epilepsy Res. 2014 Oct;108(8):1352-6. doi: 10.1016/j.eplepsyres.2014.06.008. Epub 2014 Jul 6.
- Individual participant dataSharing planned: Undecided
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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. Samikha Sarker, 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 D in people with Epilepsy, 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 7 inclusion and 25 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 25 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 ext. 94, 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 effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085598, which also lists 1 linked publication.
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 25 Jul 2025.