Menu
Recruiting NCT07084597

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

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 51 years — 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bangladesh
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • Vitamin D3 supplementation has effect on cardiac autonomic nerve function in male Parkinson's disease patient [Time frame: 8 weeks]

Eligibility 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Bangladesh · 1 center
  • Bangladesh Medical University — Dhaka

Identifiers

NCT: NCT07084597 · 5600

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗