Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Parkinson's Disease Patients With Hypovitaminosis D

NCT07084597 | Recruiting

• 1 other identifier: 5600
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to see the effect of vitamin D3 supplementation on cardiac autonomic nerve function in male Parkinson's disease patients with hypovitaminosis D Main questions it aims to answer are:

1. 1.Does vitamin D improves heart rate variability(HRV) in male Parkinson's disease patients ?
2. 2.Does vitamin D improves cardiac autonomic nerve function in male Parkinson's disease patients ? It is a self control trial. Vitamin D3 deficient Parkinson's disease participants will

Conditions

Parkinson Disease

Keywords

Vitamin D3; HRV; Hypovitaminosis D; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Vitamin D3 supplementation has effect on cardiac autonomic nerve function in male Parkinson's disease patient

  Altered cardiac autonomic nerve function

  8 weeks

Study Arms (1)

15 male Parkinson's disease patients

EXPERIMENTAL

15 male Parkinson's disease patients with hypovitaminosis D will be enrolled. They will be supplemented with vitamin D orally 50,000 IU/weeks for 8 weeks

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D ,50000 IU/week will be given for 8 consecutive weeks

15 male Parkinson's disease patients

Eligibility Criteria

• Age: 51 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with of Parkinson's disease diagnosed by neurologist with unilateral or bilateral involvement and mild to moderate disability according to Hoehn and Yahr (H-Y) scale (I-III)
• Age: 51-70 years
• BMI: 18.5-24.9 kg/m2
• Vitamin D3 deficient or insufficient
• On Levodopa medication

You may not qualify if:

• Patients with a history of drug abuse including alcoholism.
• Patients on following drugs will be excluded-
• Antioxidant vitamin supplements
• Lipid lowering medications
• Antihypertensive drug
• Anti-arrhythmic drug
• Sedatives
• All patients with the history of or clinical manifestation of currently suffering from following diseases \& condition will be excluded
• Severe Cardiovascular disorders
• Severe neurological disorders
• Severe Respiratory disorders
• Severe Renal insufficiency (S. Creatinine \> 1.5 mg/dl, Acute or chronic kidney disease)
• Severe Endocrine disease
• Severe Arthritis
• Severe Liver diseases

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Registrar BMU

CONTACT

+880255165708; registrar@bsmmu.edu.bd

Jobayda Jobayda, MBBS,MD resident,Phase B

CONTACT

01773845305; jbinterohmotullah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident

Model Details: 15 male Parkinson's disease patients with hypovitaminosis D will be enrolled

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)