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

Recruiting · NCT07096336 · Interventional (participants receive a specific treatment) · Lead sponsor: Bangladesh Medical University

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Parkinson's disease

Interventions studied

vitamin D3 capsule

What this trial is about

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.

Who can take part

Age range

51 Years to 70 Years

Sex

Male

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Bangladesh medical university - Dhaka, Shahbag, Bangladesh

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →