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

NCT ID: NCT07084597

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-10-31

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. Does vitamin D improves heart rate variability(HRV) in male Parkinson's disease patients ?

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

a. undergo through baseline HRV test b. Then they will take vitamin D3 capsule 50000 IU once in a week for 8 consecutive weeks c. Then after intervention with vitamin D supplementation post interventional HRV will be done.

Researcher will compare pre intervention(pre test) and post intervention(post test) value of HRV

Detailed Description

In Parkinson's disease , there is a shifting of autonomic nerve function towards sympathetic dominance and Heart rate variability decrease. Reduced heart rate variability can be detected by Heart rate variability(HRV) testing.

In Parkinson's disease deposition of Lewy bodies (due to accumulation of alpha- synuclein protein ) causes degeneration of dopaminergic neuron. Parasympathetic nerve results from vagus nerve atrophy and simultaneous sympathetic denervation results in decrease HRV.

Hypovitaminosis D is commonly associated with Parkinson's disease due to alteration of gastrointestinal function, progressive skin atrophy, lack of mobilization, lack of sun exposure.

Vitamin D3 act as neuroprotective hormone and plays role in autonomic nervous system regulation and maintaining balance between sympathetic and parasympathetic nervous system. Vitamin D3 deficiency is associated with cardiac autonomic imbalance. Administration of vitamin D3 in vitamin D deficient Parkinson's patient may may improve cardiac autonomic nerve function that can be interpreted by HRV.

Conditions

Parkinson Disease

Study Design

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

Study Groups

15 male Parkinson's disease patients

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Vitamin D

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

1. Patients with a history of drug abuse including alcoholism.

2. Patients on following drugs will be excluded-

• Antioxidant vitamin supplements
• Lipid lowering medications
• Antihypertensive drug
• Anti-arrhythmic drug
• Sedatives

3. 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
• Severe Neoplastic disease
• Severe Psychiatric disorder
• Current use of iron, zinc, calcium, magnesium and multivitamin supplementation
• Already performing yoga or breathing exercise
• Hypercalcemia

• 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

Jobayda Binte Rahmatullah

MD Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bangladesh Medical University

Dhaka, Shahbag, Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Registrar BMU

Role: CONTACT

registrar@bsmmu.edu.bd

+880255165708 ext. 94

Jobayda Jobayda, MBBS,MD resident,Phase B

Role: CONTACT

jbinterohmotullah@gmail.com

01773845305

Other Identifiers

5600

Identifier Type: -

Identifier Source: org_study_id