Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D
Launched by BANGLADESH MEDICAL UNIVERSITY · Jul 24, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether taking vitamin D3 supplements can improve heart nerve function in men with epilepsy who have low levels of vitamin D. The researchers want to find out if vitamin D can help regulate the heart’s activity by measuring something called heart rate variability, which shows how well the nerves control the heart. This study is important because people with epilepsy and low vitamin D might have changes in heart function that could affect their health.
Men between the ages of 20 and 40 who have been diagnosed with epilepsy and have low vitamin D levels may be eligible to join. Participants must be taking specific epilepsy medications but not others, and they should not have certain other health problems like heart disease, diabetes, or kidney issues. If accepted, participants will have their heart activity tested at the start, then take a weekly vitamin D3 pill for 8 weeks, and finally have their heart activity tested again. This helps the researchers see if vitamin D made a difference. If you or a family member fits these criteria and are interested, this study could offer helpful information about managing epilepsy and heart health together.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • • 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).
- Exclusion Criteria:
- • • 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
About Bangladesh Medical University
Bangladesh Medical University is a leading academic institution dedicated to advancing medical research and education in Bangladesh. As a clinical trial sponsor, the university is committed to promoting innovative healthcare solutions through rigorous scientific investigation and collaboration with local and international research partners. With a focus on ethical practices and patient safety, Bangladesh Medical University aims to contribute to the global medical community by conducting high-quality clinical trials that address pressing health challenges and improve patient outcomes in diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dhaka, Shahbag, Bangladesh
Patients applied
Trial Officials
Dr. Samikha Sarker, MBBS, MD Resident (Phase B)
Principal Investigator
BMU
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported