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

Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07084597
Enrollment
15
Registered
2025-07-24
Start date
2025-07-31
Completion date
2025-10-31
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Vitamin D3, HRV, Hypovitaminosis D, Parkinson disease

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

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

Sponsors

Bangladesh Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
51 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

IInclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Vitamin D3 supplementation has effect on cardiac autonomic nerve function in male Parkinson's disease patient8 weeksAltered cardiac autonomic nerve function

Countries

Bangladesh

Contacts

Primary ContactRegistrar BMU
registrar@bsmmu.edu.bd+880255165708
Backup ContactJobayda Jobayda, MBBS,MD resident,Phase B
jbinterohmotullah@gmail.com01773845305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026