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

NCT07085598 | Recruiting

• 1 other identifier: 5592
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does vitamin D improves cardiac autonomic tone in male epileptic patients?
2. 2.Does vitamin D improves heart rate variability in male epileptic patients?
3. 3.undergo through baseline HRV testing
4. 4.start to take vitamin D3 50000 IU once in a week for 8 weeks

Conditions

Epilepsy

Keywords

Vitamin D3; Hypovitaminosis D; HRV

Outcome Measures

Primary Outcomes (1)

• Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D.

  In epilepsy, cardiac autonomic nerve function is altered which can be measured by heart rate variability test(HRV). HRV is reduced in epilepsy. Vitamin D3 supplementation in patients with epilepsy will improve their cardiac autonomic nerve function which can be detected by measuring various parameters of HRV test such as SDRR, LF(Low frequency).

  8 weeks

Study Arms (1)

15 male epileptic patients with hypovitaminosis D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

15 male epileptic patients with hypovitaminosis D

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr. Samikha Sarker, MBBS, MD Resident (Phase B)

  BMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Registrar, BMU

CONTACT

+88 02 55165708; registrar@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 15 epileptic patients with hypovitaminosis D will be enrolled

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 25, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

BA (1)