Vitamin D3 to improve heart nerve function in men with epilepsy and low vitamin D
Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D
This will give men aged 20–40 who have epilepsy and low vitamin D a weekly 50,000 IU dose of vitamin D3 for 8 weeks to see if their heart rate variability improves.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Male |
| Sponsor | Bangladesh Medical University Academic / other |
| Locations | 1 site (Dhaka, Shahbag) |
| Trial ID | NCT07085598 on ClinicalTrials.gov |
What this trial studies
This is a self‑controlled pre/post intervention in which enrolled male patients undergo baseline heart rate variability (HRV) testing, receive vitamin D3 50,000 IU once weekly for 8 weeks, and return for repeat HRV testing. Participants are men age 20–40 with epilepsy, BMI 18.5–24.9 kg/m2, on enzyme‑inducing antiepileptic drugs, and with serum vitamin D3 <30 ng/ml. Investigators will compare pre‑treatment and post‑treatment HRV measures to determine change in cardiac autonomic tone. The study is conducted at Bangladesh Medical University in Dhaka.
Who should consider this trial
Good fit: Men aged 20–40 with a diagnosed epilepsy, BMI 18.5–24.9, on enzyme‑inducing AEDs for 6 months–2 years, and a serum vitamin D3 level <30 ng/ml who are not taking excluded medications or substances.
Not a fit: Patients who are female, outside the age or BMI ranges, have absence seizures, are smokers or alcoholics, or who take excluded drugs or non‑enzyme‑inducing AEDs (e.g., valproate, levetiracetam) are unlikely to be eligible and may not benefit from this protocol.
Why it matters
Potential benefit: If successful, correcting vitamin D deficiency could improve cardiac autonomic balance and heart rate variability, which may reduce cardiac risk in these patients.
How similar studies have performed: Small prior studies have suggested vitamin D repletion can affect autonomic markers like HRV, but the evidence is limited and inconsistent.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka, Shahbag
- Bangladesh Medical University — Dhaka, Shahbag, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Dr. Samikha Sarker, MBBS, MD Resident (Phase B) — Bmu
- Study coordinator: Registrar, BMU
- Email: registrar@bsmmu.edu.bd
- Phone: +88 02 55165708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.