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Recruiting NCT07085598

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

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 20 years — 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bangladesh
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

  • Dietary supplement Vitamin 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

Primary outcome measures

  • Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D. [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Bangladesh · 1 center
  • Bangladesh Medical University — Dhaka

Publications

  • Teagarden DL, Meador KJ, Loring DW. Low vitamin D levels are common in patients with epilepsy. Epilepsy Res. 2014 Oct;108(8):1352-6. doi: 10.1016/j.eplepsyres.2014.06.008. Epub 2014 Jul 6. PMID 25060996

Identifiers

NCT: NCT07085598 · 5592

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗