PARKINSON DISEASE (Disorder)
Conditions
Keywords
Parkinson's disease, Vitamin D3, Quantitative EEG (qEEG), Brain wave, 25-hydroxyvitamin D, Spectral power, Dopaminergic neurons, EEG frequency bands, Neurodegeneration
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.
Detailed description
This self-controlled experimental study will be conducted at the Department of Physiology, BMU, Dhaka, between March 2025 and February 2026. Fifteen male patients with Parkinson's disease (PD) and confirmed hypovitaminosis D will be recruited from the Neurology Outpatient Department. Each participant will undergo serum 25(OH)D level assessment and baseline EEG recording (Session A1). Following this, they will receive vitamin D3 supplementation orally (50,000 IU weekly) for 8 weeks. After the intervention period, serum 25-hydroxyvitamin D level will be reassessed and EEG recording will be done again (Session AD). The EEG data will be collected using an EEG Traveler BrainTech 32+ CMEEG-01 device using Fast Fourier Transform (FFT) to derive spectral parameters including absolute power, relative power, peak power frequency (PPF), median power frequency (MPF), and spectral edge frequency (SEF) across delta, theta, alpha, and beta frequency bands. Statistical analysis will be performed using SPSS version 25. Data will be tested for normality using the Shapiro-Wilk test. Paired t-tests or Wilcoxon signed-rank tests will be applied for within-group comparisons, with statistical significance set at p ≤ 0.05. This research aims to fill this gap by using quantitative EEG to investigate if vitamin D3 supplementation modulates brain electrical activity in PD patients who are deficient or insufficient in vitamin D. The findings could contribute to a better understanding of the neurophysiological effects of vitamin D3 and support its potential as an adjunctive therapeutic strategy in managing PD.
Interventions
DIETARY_SUPPLEMENTvitamin D3 capsule
Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks
Sponsors
Bangladesh Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Masking Description
Intervention model description
Experimental study ( Interventional self controlled experimental trial) where 15 participants will be enrolled to compare their baseline data with post interventional data
Eligibility
Sex/Gender
MALE
Age
51 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in absolute power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks | 8 weeks | Measured using FFT-based quantitative EEG (qEEG) analysis. Unit of Measure: microvolts squared (µV²) |
| Change in relative power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks | 8 weeks | Measured using FFT-based quantitative EEG (qEEG) analysis. Unit of Measure: percentage (%) |
| Change in peak power frequency in alpha, beta, theta, and delta bands from baseline to 8 weeks | 8 weeks | Measured from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz) |
| Change in median power frequency from baseline to 8 weeks | 8 weeks | Measured from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz) |
| Change in spectral edge frequency (SEF 90) from baseline to 8 weeks | 8 weeks | Calculated from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz) |
Countries
Bangladesh
Outcome results
None listed