RecruitingNot ApplicableNCT07085598

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


Sponsor

Bangladesh Medical University

Enrollment

15 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 20 YearsMax Age: 40 Years

Inclusion Criteria7

  • 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 Criteria25

  • 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

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Interventions

DIETARY_SUPPLEMENTVitamin D

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


Locations(1)

Bangladesh Medical University

Dhaka, Shahbag, Bangladesh

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NCT07085598


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