Effect of Vitamin D3 on Brain Waves in Male Parkinson's Patients With Low Vitamin D: A qEEG Study

NCT07096336 | Recruiting

• 1 other identifier: 5586
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is an experimental study (Interventional self-controlled trial, pretest-posttest design). The goal of this clinical trial is to evaluate the effect of vitamin D3 supplementation on quantitative EEG in male Parkinson's disease patients with hypovitaminosis D. The main question it aims to answer is: Vitamin D3 supplementation has effect on brain waves in male Parkinson's disease patients with hypovitaminosis D. Researcher will compare the effect of vitamin D3 supplementation on brain waves in male Parkinson's disease patients with hypovitaminosis D with their pre intervention ( baseline ) condition on brain waves to assess whether there will be any improvement of brain electrical activity by quantitative electroencephalogram (QEEG). Participants will : Take vitamin D3 orally for 8 weeks (50,000 IU/week) Visit the medical university after 8 weeks for evaluation of serum 25(OH)D level and QEEG Must bring the empty strips of vitamin D supplement with them during their visit.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson's disease; Vitamin D3; Quantitative EEG (qEEG); Brain wave; 25-hydroxyvitamin D; Spectral power; Dopaminergic neurons; EEG frequency bands; Neurodegeneration

Outcome Measures

Primary Outcomes (5)

• Change in absolute power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks

  Measured using FFT-based quantitative EEG (qEEG) analysis. Unit of Measure: microvolts squared (µV²)

  8 weeks

• Change in relative power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks

  Measured using FFT-based quantitative EEG (qEEG) analysis. Unit of Measure: percentage (%)

  8 weeks

• Change in peak power frequency in alpha, beta, theta, and delta bands from baseline to 8 weeks

  Measured from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz)

  8 weeks

• Change in median power frequency from baseline to 8 weeks

  Measured from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz)

  8 weeks

• Change in spectral edge frequency (SEF 90) from baseline to 8 weeks

  Calculated from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz)

  8 weeks

Study Arms (1)

Male Parkinson's disease patients with hypovitaminosis D

EXPERIMENTAL

15 Male Parkinson's disease patients with hypovitaminosis D will be supplemented with vitamin D orally 50,000 IU/week for 8 weeks

Dietary Supplement: vitamin D3 capsule

Interventions

vitamin D3 capsule DIETARY_SUPPLEMENT

Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks

Male Parkinson's disease patients with hypovitaminosis D

Eligibility Criteria

• Age: 51 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male Patients with PD up to stage 3 according to Hoehn and Yahr (H-Y) scale
• Age: 51years to70 years
• BMI: 18.5-24.9 kg/m2
• Hypovitaminosis D (Serum 25(OH)D level \<30 ng/ml)
• Patients on Levodopa therapy

You may not qualify if:

• Already taking vitamin D3 supplements
• Current use of medication/substances known to affect neuronal excitability or EEG patterns, such as - sedatives, antidepressant, antipsychotics, alcohol.
• Patients who are currently suffering from following diseases
• Neurological disorders (Migraine, epilepsy)
• Cardiovascular disorders (Myocardial infarction, hypertension, cardiac arrhythmia, heart failure)
• Respiratory disorders (Bronchial asthma, COPD)
• Psychiatric illness (e.g., schizophrenia, major depression, bipolar disorder, severe dementia)
• With biochemical evidence of-
• Hypercalcemia
• Renal insufficiency
• Liver diseases
• Endocrine disorders (uncontrolled diabetes mellitus, Hypothyroidism, Hyperthyroidism)
• Active smoker

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh medical university

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Nerve Degeneration

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD resident , Department of Physiology, Bangladesh Medical University, Principal investigator,

Model Details: Experimental study ( Interventional self controlled experimental trial) where 15 participants will be enrolled to compare their baseline data with post interventional data

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: July 15, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)