Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D

Last updated: July 24, 2025
Sponsor: Bangladesh Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Bone Diseases

Treatment

Vitamin D

Clinical Study ID

NCT07085598
5592
  • Ages 20-40
  • Male

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Diagnosed male patients with Epilepsy by neurologist from the OPD of Department ofNeurology by taking proper history of at least two unprovoked (or reflex) seizuresoccuring > 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 thanantiepileptic drugs (AEDs).

Exclusion

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 kidneydisease)

  • 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 multivitaminsupplementation

  • Already performing yoga or breathing exercise

  • Patients with hypercalcemia

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Vitamin D
Phase:
Study Start date:
July 01, 2025
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Bangladesh Medical University

    Dhaka, Shahbag 1000
    Bangladesh

    Active - Recruiting

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