NCT07085598Recruiting
Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. Does vitamin D improves cardiac autonomic tone in male epileptic patients? 2. Does vitamin D improves heart rate variability in male epileptic patients? It is a self control trial. Participants will: 1. undergo through baseline HRV testing 2. start to take vitamin D3 50000 IU once in a week for 8 weeks b) visit the university after 8 weeks for post interventional HRV testing . Researcher will compare the pre test and post test value of HRV testing.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 12 Jul 2025
- Start date
- Jul 2025
- Primary completion date
- Oct 2025
- Lead sponsor
- Bangladesh Medical University
- Diseases
- Epilepsy
- NCT number
- NCT07085598
What you commit to
- Study type: Interventional
- Planned participants: 15
- From Jul 2025 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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
- 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
Who the study is looking for
- • 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).
Age in the registry: 20 years to 40 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bangladesh Medical University Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.