Parkinson DiseaseNCT07084597
Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Parkinson's Disease Patients With Hypovitaminosis D
A study testing Vitamin D in people with Parkinson Disease, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 51 to 70 years, men only
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, Shahbag, 1000
Jobayda Jobayda, MBBS,MD(Phase B)
About this study
Official title: Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male
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:
Read more
- Does vitamin D improves heart rate variability(HRV) in male Parkinson's disease patients ?
- 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
- 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
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- Vitamin D
- Keywords
- Vitamin D3, HRV, Hypovitaminosis D, Parkinson disease
- Medical subject headings
- Parkinson Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D ,50000 IU/week will be given for 8 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| 15 male Parkinson's disease patients | Experimental | 15 male Parkinson's disease patients with hypovitaminosis D will be enrolled. They will be supplemented with vitamin D orally 50,000 IU/weeks for 8 weeks Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D3 supplementation has effect on cardiac autonomic nerve function in male Parkinson's disease patient
Altered cardiac autonomic nerve function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 15 male Parkinson's disease patients with hypovitaminosis D will be enrolled
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jobayda Binte Rahmatullah, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084597
- Sponsor's protocol ID
- 5600
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male
- ClinicalTrials.gov ID
- NCT07084597
- Acronym / sponsor ID
- 5600
- Conditions
- Parkinson Disease
- Keywords
- Vitamin D3, HRV, Hypovitaminosis D, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does vitamin D improves heart rate variability(HRV) in male Parkinson's disease patients ?
- 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
- 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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 male Parkinson's disease patients with hypovitaminosis D will be enrolled
| Arm | Type | Receives |
|---|---|---|
| 15 male Parkinson's disease patients | Experimental | Dietary Supplement: Vitamin D15 male Parkinson's disease patients with hypovitaminosis D will be enrolled. They will be supplemented with vitamin D orally 50,000 IU/weeks for 8 weeks |
Who may qualify
- Ages
- 51 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Patients with a history of drug abuse including alcoholism.
- Patients on following drugs will be excluded-
- All patients with the history of or clinical manifestation of currently suffering from following diseases \& condition will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DVitamin D ,50000 IU/week will be given for 8 consecutive weeks | Dietary supplement | 15 male Parkinson's disease patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Parkinson Disease, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Registrar BMU (+880255165708 ext. 94, registrar@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D3 supplementation has effect on cardiac autonomic nerve function in male Parkinson's disease patient (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.