Vitamin D3 for heart rate variability in men with Parkinson's and low vitamin D

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

This trial will test whether taking a weekly 50,000 IU vitamin D3 capsule for eight weeks improves heart rate variability and cardiac autonomic nerve function in men (51–70) with Parkinson's disease who have low vitamin D.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 51 Years to 70 Years
• Sex: Male
• Sponsor: Bangladesh Medical University (Academic / other)
• Locations: 1 site (Dhaka, Shahbag)
• Trial ID: NCT07084597 on ClinicalTrials.gov

What this trial studies

Male Parkinson's patients aged 51–70 with vitamin D deficiency or insufficiency and mild-to-moderate disease (Hoehn and Yahr I–III) will undergo baseline heart rate variability (HRV) testing, then receive 50,000 IU vitamin D3 once weekly for eight weeks, followed by repeat HRV testing. This is a self-controlled pre–post interventional design comparing each participant's HRV before and after supplementation. Participants must be on levodopa, meet BMI criteria (18.5–24.9 kg/m2), and not have severe cardiovascular, renal, hepatic, respiratory, endocrine, or neurological comorbidities or take excluded medications. The primary outcome is change in HRV parameters as markers of cardiac autonomic balance.

Who should consider this trial

Good fit: Ideal candidates are men aged 51–70 with Parkinson's disease (Hoehn and Yahr I–III), BMI 18.5–24.9, confirmed vitamin D insufficiency or deficiency, currently on levodopa, and without severe comorbidities or excluded medications.

Not a fit: Patients who are female, outside the age or BMI ranges, have normal vitamin D levels, have severe organ disease, or are taking excluded medications are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, supplementation could improve cardiac autonomic balance and heart rate variability, potentially lowering cardiovascular risk in men with Parkinson's and vitamin D deficiency.

How similar studies have performed: Prior observational studies link vitamin D status to autonomic function and small interventional studies suggest possible HRV improvements, but randomized and Parkinson's-specific evidence is limited.

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:

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

Where this trial is running

Dhaka, Shahbag

• Bangladesh Medical University — Dhaka, Shahbag, Bangladesh (Recruiting)

Study contacts

• Study coordinator: Registrar BMU

Conditions Parkinson Disease; Vitamin D3; HRV; Hypovitaminosis D; Parkinson disease