跳至主要内容
临床试验/NCT07096336
NCT07096336招募中不适用

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

Bangladesh Medical University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
2
主要终点
Change in absolute power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

Masking Description

入排标准

年龄范围
51 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 8 weeks

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

次要结局

未报告次要终点

研究者

发起方
Bangladesh Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jannatul Ferdoush Sumi

MD resident , Department of Physiology, Bangladesh Medical University, Principal investigator,

Bangladesh Medical University

研究点 (2)

Loading locations...

相似试验