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NCT Number: NCT07084597

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

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

Recruiting

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Key information

Age range

51 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

Location status: Recruiting

Location contact

Jobayda Jobayda, MBBS,MD(Phase B)

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

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

Primary outcomes

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

    Time frame: 8 weeks

    Altered cardiac autonomic nerve function

Study contacts

Contact information is provided by the study sponsor or research team.

Jobayda Jobayda, MBBS,MD resident,Phase B

CONTACT

[email protected]

01773845305

Registrar BMU

CONTACT

[email protected]

+880255165708 ext. 94

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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