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

NCT ID: NCT07096336

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-11-30

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.

Conditions

PARKINSON DISEASE (Disorder)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Male Parkinson's disease patients with hypovitaminosis D

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

Group Type: EXPERIMENTAL

vitamin D3 capsule

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

vitamin D3 capsule

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 51 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bangladesh Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jannatul Ferdoush Sumi

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bangladesh medical university

Dhaka, Shahbag, Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Facility Contacts

Jannatul Ferdoush Sumi, MBBS, MD Resident (phase B)

Role: primary

jannatsumi37@gmail.com

+8801875236686

SUAYYA BINTE RAZZAQUE, MBBS,MD RESIDENT PHASE B

Role: backup

+ 8801731660607

Other Identifiers

5586

Identifier Type: -

Identifier Source: org_study_id