PARKINSON DISEASE (Disorder)NCT07096336
Effect of Vitamin D3 on Brain Waves in Male Parkinson's Patients With Low Vitamin D: A qEEG Study
A study testing vitamin D3 capsule in people with PARKINSON DISEASE (Disorder), run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 to 70 years, men only
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- vitamin D3 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Jul 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh medical university
Dhaka, Shahbag, 1000
Jannatul Ferdoush Sumi, MBBS, MD Resident (phase B), +8801875236686, jannatsumi37@gmail.com
SUAYYA BINTE RAZZAQUE, MBBS,MD RESIDENT PHASE B, + 8801731660607
About this study
Official title: Effect of Vitamin D3 Supplementation on Brain Waves in Male Parkinson's Disease Patients With Hypovitaminosis D : A Quantitative Electroencephalogram Analysis
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:
Read more
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.
Read the 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)
- Being tested
- vitamin D3 capsule
- Keywords
- Parkinson's disease, Vitamin D3, Quantitative EEG (qEEG), Brain wave, 25-hydroxyvitamin D, Spectral power, Dopaminergic neurons, EEG frequency bands, Neurodegeneration
- Medical subject headings
- Parkinson Disease, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3 capsuleDietary supplement
Administration of vitamin D3 capsule 50,000 IU/week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Male Parkinson's disease patients with hypovitaminosis D | Experimental | 15 Male Parkinson's disease patients with hypovitaminosis D will be supplemented with vitamin D orally 50,000 IU/week for 8 weeks Receives: Dietary Supplement: vitamin D3 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
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 (%)
Measured: 8 weeks
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)
Measured: 8 weeks
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)
Measured: 8 weeks
Change in spectral edge frequency (SEF 90) from baseline to 8 weeks
Calculated from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Jul 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental study ( Interventional self controlled experimental trial) where 15 participants will be enrolled to compare their baseline data with post interventional data
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jannatul Ferdoush Sumi, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096336
- Sponsor's protocol ID
- 5586
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Brain Waves in Male Parkinson's Disease Patients With Hypovitaminosis D : A Quantitative Electroencephalogram Analysis
- ClinicalTrials.gov ID
- NCT07096336
- Acronym / sponsor ID
- 5586
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson's disease, Vitamin D3, Quantitative EEG (qEEG), Brain wave, 25-hydroxyvitamin D, Spectral power, Dopaminergic neurons, EEG frequency bands
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental study ( Interventional self controlled experimental trial) where 15 participants will be enrolled to compare their baseline data with post interventional data
| Arm | Type | Receives |
|---|---|---|
| Male Parkinson's disease patients with hypovitaminosis D | Experimental | Dietary Supplement: vitamin D3 capsule15 Male Parkinson's disease patients with hypovitaminosis D will be supplemented with vitamin D orally 50,000 IU/week for 8 weeks |
Who may qualify
- Ages
- 51 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- With biochemical evidence of-
- Active smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3 capsuleAdministration of vitamin D3 capsule 50,000 IU/week for 8 weeks | Dietary supplement | Male Parkinson's disease patients with hypovitaminosis D |
Primary outcome
Change in absolute power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Calculated from global EEG spectrum using FFT-based qEEG analysis. Unit of Measure: Hertz (Hz)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 capsule in people with PARKINSON DISEASE (Disorder), run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absolute power in alpha, beta, theta, and delta frequency bands from baseline to 8 weeks (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.