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

Bangladesh Medical University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT07084597

5600

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 51 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

15 male Parkinson's disease patients

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D