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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age51-70
SponsorBangladesh Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • vitamin D3 capsule

    Dietary supplement

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Male Parkinson's disease patients with hypovitaminosis DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
8 weeks
2

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 (%)

Time frame
8 weeks
3

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)

Time frame
8 weeks
4

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)

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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