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.
| 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) |
Vitamin D deficiency has been increasingly recognized as a potential modifiable risk factor in Parkinson's disease[1]. Preclinical and clinical evidence suggests that vitamin D may play neuroprotective roles through multiple mechanisms:
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[2].
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.
| Parameter | Value |
|---|---|
| Drug | Vitamin D3 (Cholecalciferol) |
| Dose | 50,000 IU per week |
| Route | Oral |
| Duration | 8 weeks |
| Arm | Single treatment arm (open label) |
| 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 |
| 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 |
Vitamin D receptors (VDR) are widely distributed throughout the brain, including in regions affected in Parkinson's disease:
The presence of VDR in dopaminergic neurons suggests that vitamin D may directly modulate dopaminergic function and survival.
Evidence suggests that vitamin D deficiency may:
The 50,000 IU weekly dose is a standard repletion regimen for vitamin D deficiency:
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.
Chetram J, Mahesh R, et al. Vitamin D and Parkinson's disease: Emerging therapeutic implications. Journal of Neural Transmission. 2024. ↩︎
Simeon R, Muller T. Vitamin D deficiency in Parkinson's disease: Clinical implications. Neurology International. 2023. ↩︎