Stabilize heart and blood pressure
- Trial ID
- NCT07084597
- Official Title
- Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male
- Goal
- Stabilize heart and blood pressure
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Bangladesh Medical University
- Study Type
- INTERVENTIONAL
- Enrollment
- 15 participants
- Conditions
- Parkinson Disease
- Interventions
- Vitamin D
Summary For Families
It's testing whether correcting vitamin D3 deficiency can improve cardiac autonomic nerve function, which in Parkinson's can show up as abnormal heart rate variability and blood pressure changes. Participants will take vitamin D3 to raise blood levels, because vitamin D helps regulate calcium balance and has anti-inflammatory and neuroprotective effects that may stabilize autonomic signaling to the heart, and the supplement is given alongside levodopa while calcium levels are monitored. Men aged 51 to 70 with mild to moderate Parkinson's (Hoehn and Yahr I,III), BMI 18.5,24.9, who are vitamin D deficient or insufficient and are taking levodopa are eligible. People with major organ disease, hypercalcemia, current use of antioxidant vitamins or certain heart, blood pressure or sedative drugs, or those already doing yoga or breathing exercises are excluded.
Locations
- Bangladesh Medical University, Dhaka, Shahbag, Bangladesh
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Vitamin D. It's testing whether correcting vitamin D3 deficiency can improve cardiac autonomic nerve function, which in Parkinson's can show up as abnormal heart rate variability and blood pressure changes. Participants will take vitamin D3 to raise blood levels, because vitamin D helps regulate calcium balance and has anti-inflammatory and neuroprotective effects that may stabilize autonomic signaling to the heart, and the supplement is given alongside levodopa while calcium levels are monitored. Men aged 51 to 70 with mild to moderate Parkinson's (Hoehn and Yahr I,III), BMI 18.5,24.9, who are vitamin D deficient or insufficient and are taking levodopa are eligible. People with major organ disease, hypercalcemia, current use of antioxidant vitamins or certain heart, blood pressure or sedative drugs, or those already doing yoga or breathing exercises are excluded.
- Who can participate?
- Participants must be between 51 Years and 70 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 3 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.