Vitamin D3 Cardiac Autonomic PD Trial (NCT07084597)

Overview

This clinical trial investigates the effect of Vitamin D3 supplementation on cardiac autonomic nerve function in male Parkinson's disease patients with hypovitaminosis D. Conducted at Bangladesh Medical University, the study addresses a critical gap in understanding how vitamin D status may influence autonomic dysfunction in PD, a common non-motor symptom affecting quality of life and prognosis.

Trial Details

Overview

This clinical trial investigates the effect of Vitamin D3 supplementation on cardiac autonomic nerve function in male Parkinson's disease patients with hypovitaminosis D. Conducted at Bangladesh Medical University, the study addresses a critical gap in understanding how vitamin D status may influence autonomic dysfunction in PD, a common non-motor symptom affecting quality of life and prognosis.

Trial Details

| Attribute | Value |
|-----------|-------|
| NCT Number | NCT07084597 |
| Title | Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Parkinson's Disease Patients With Hypovitaminosis D |
| Official Title | Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Parkinson's Disease Patients With Hypovitaminosis D |
| Status | Not Yet Recruiting |
| Phase | Not Applicable |
| Study Type | Interventional |
| Design | Single Group Assignment |
| Allocation | N/A (Single arm) |
| Masking | None (Open Label) |
| Enrollment | 15 patients (estimated) |
| Sponsor | Bangladesh Medical University |
| Principal Investigator | To be determined |
| Location | Bangladesh Medical University, Dhaka, Bangladesh |
| Start Date | July 2025 (estimated) |
| Primary Completion | October 2025 (estimated) |
| Completion | October 2025 (estimated) |

Rationale

Vitamin D and Neurodegeneration

Vitamin D deficiency has been increasingly recognized as a potential modifiable risk factor in Parkinson's disease[@chets2024]. Preclinical and clinical evidence suggests that vitamin D may play neuroprotective roles through multiple mechanisms:

• Anti-inflammatory effects: Vitamin D modulates microglial activation and reduces pro-inflammatory cytokines
• Neurotrophic support: Promotes synthesis of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF)
• Calcium homeostasis: Regulates intracellular calcium flux, preventing excitotoxicity
• Antioxidant properties: Enhances antioxidant enzyme expression

Autonomic Dysfunction in PD

Cardiac autonomic dysfunction is common in Parkinson's disease, manifesting as orthostatic hypotension, supine hypertension, heart rate variability abnormalities, and baroreflex impairment. These symptoms significantly impact quality of life and may precede motor symptoms by years[@simeon2023].

The relationship between vitamin D status and cardiac autonomic function in PD patients remains poorly understood, representing a critical knowledge gap that this trial aims to address.

Intervention

| Parameter | Value |
|-----------|-------|
| Drug | Vitamin D3 (Cholecalciferol) |
| Dose | 50,000 IU per week |
| Route | Oral |
| Duration | 8 weeks |
| Arm | Single treatment arm (open label) |

Outcome Measures

Primary Outcomes

| Measure | Description | Timeframe |
|---------|-------------|-----------|
| Cardiac Autonomic Nerve Function | Evaluation of autonomic nervous system function through heart rate variability (HRV) measurements and other cardiac autonomic tests | Change from baseline to 8 weeks |

Secondary Outcomes (Anticipated)

| Measure | Description | Timeframe |
|---------|-------------|-----------|
| Serum Vitamin D Level | 25-hydroxyvitamin D concentration | Change from baseline to 8 weeks |
| Motor Symptoms | MDS-UPDRS or Hoehn & Yahr staging | Change from baseline to 8 weeks |
| Blood Pressure | Orthostatic blood pressure measurements | Change from baseline to 8 weeks |
| Heart Rate Variability | Time-domain and frequency-domain HRV parameters | Change from baseline to 8 weeks |

Eligibility Criteria

Inclusion Criteria

• Male patients with Parkinson's disease
• Age: 51-70 years
• Parkinson's disease diagnosed by a qualified neurologist
• Hoehn & Yahr scale: Stage I-III
• BMI: 18.5-24.9 kg/m²
• Vitamin D deficient or insufficient (as defined by serum 25(OH)D levels)
• Currently receiving Levodopa medication

Exclusion Criteria

• Drug abuse or alcoholism
• Current supplementation with iron, zinc, calcium, magnesium, or multivitamins
• Use of antioxidants, lipid-lowering agents, antihypertensives, anti-arrhythmics, or sedatives
• Severe cardiovascular disorders
• Severe neurological disorders (other than PD)
• Severe respiratory, renal, endocrine, hepatic, or psychiatric disorders

Demographics

• Sex: Male only
• Minimum Age: 51 years
• Maximum Age: 70 years
• Healthy Volunteers: No

Scientific Context

Vitamin D and the Brain

Vitamin D receptors (VDR) are widely distributed throughout the brain, including in regions affected in Parkinson's disease:

• Substantia nigra
• [Hippocampus](/brain-regions/hippocampus)
• [Hypothalamus](/brain-regions/hypothalamus)
• Cerebral cortex

Autonomic Nervous System and Vitamin D

Evidence suggests that vitamin D deficiency may:

• Increase sympathetic activity
• Reduce baroreflex sensitivity
• Impair heart rate variability
• Contribute to cardiovascular mortality

Why 50,000 IU Weekly?

The 50,000 IU weekly dose is a standard repletion regimen for vitamin D deficiency:

• Achieves rapid correction of deficiency
• Maintains therapeutic levels with weekly dosing
• Commonly used in clinical practice for severe deficiency

Clinical Significance

This trial addresses several important questions:

If positive, this study could establish vitamin D as a standard adjunct therapy for PD patients with hypovitaminosis D, particularly those with autonomic symptoms.

References

See Also

• [Brain-Derived Neurotrophic Factor (BDNF)](/wiki/proteins-bdnf) — references