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Trials / Recruiting

RecruitingNCT07096336

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

Effect of Vitamin D3 Supplementation on Brain Waves in Male Parkinson's Disease Patients With Hypovitaminosis D : A Quantitative Electroencephalogram Analysis

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Bangladesh Medical University · Academic / Other
Sex
Male
Age
51 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTvitamin D3 capsuleAdministration of vitamin D3 capsule 50,000 IU/week for 8 weeks

Timeline

Start date
2025-07-15
Primary completion
2025-11-01
Completion
2025-11-01
First posted
2025-07-31
Last updated
2025-07-31

Locations

1 site across 1 country: Bangladesh

Source: ClinicalTrials.gov record NCT07096336. Inclusion in this directory is not an endorsement.