Parkinson DiseasePhase 2PDVD3NCT00907972
The Effects of Vitamin D and Bone Loss in Parkinson's Disease
A Phase 2 study testing Vitamin D3 in people with Parkinson Disease, run by Memorial Medical Center at 1 site in United States.
Trial summary
Health care burdens from neurodegenerative diseases are expected to increase disproportionately. Increasing age also predisposes this same population to other chronic diseases including osteoporosis, a progressive systemic skeletal disease characterized by low bone mass, which leads to an increase susceptibility to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be >18 yrs of age
- Subject must have a diagnosis of Parkinson's disease (Hoehn and Yahr stages I-III), confirmed by the study physician designated to complete patient staging
- Subject must sign the informed consent documentation according to MMC's IRB guidelines
- Subject must be willing and able to complete all study requirements at the designated time intervals
- Subject must agree to be randomized
- If subject has been taking a separate Vitamin D supplement other than a multivitamin within the last 6 months, the subject must be willing to discontinue Vitamin D supplement for 3 months before entering the study
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- Subject must have a vitamin D level greater than 10 ng/mL
- Subjects must have a serum calcium level within the range of 8.4-10 mg/dl.
- Females subjects of child bearing potential must have a negative urine pregnancy test or have undergone a sterilization procedure
Who cannot join
- Subjects < 18 years old
- Parkinson's disease patients with Hoehn and Yahr stages IV-V.
- Subjects not willing and able to complete all study requirements at the designated time intervals
- Subjects who do not agree to be randomized
- Subjects receiving treatment with bisphosphonates (more that 3 months), parathyroid hormones (PTH) or PTH derivatives, e.g. Teriparatide or Fluoride, in the last 6 months.
- Subjects with an allergy to the investigational product.
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- Subjects who have a vitamin D level less than 10 ng/mL
- Subjects who do not have a serum calcium level within the range of 8.4-10 mg/dl.
- Subjects who are pregnant, verified by a urine pregnancy test*
Trial locations and contacts
1 site in 1 country.
United States1 site
Conemaugh Health System - John P Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, 15904
About this study
Official title: Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study
Health care burdens from neurodegenerative diseases are expected to increase disproportionately. Increasing age also predisposes this same population to other chronic diseases including osteoporosis, a progressive systemic skeletal disease characterized by low bone mass, which leads to an increase susceptibility to fractures. In the United States, 44 million people are estimated to be at risk for osteoporosis and low bone mass emphasizing the enormity of this public health problem.
Parkinson's disease is a progressive neurodegenerative disorder affecting about 1 million people. Evidence indicates that Parkinson's disease patients are at a higher risk for low bone mineral density, which can contribute to increased fractures compared to healthy subjects. In fact, several risk factors of osteoporosis in patients with PD have been identified, including advanced stages of PD, low body mass index, inadequate sunlight exposure and decreased vitamin D levels. Some or all of these factors in conjunction with decreased immobilization that may occur with PD, put patients at increased risks for fractures. Few studies however have examined bone markers in PD patients. Even fewer studies have examined the impact of Vitamin D supplementation on bone metabolism and mineralization in PD patients.
Vitamin D is an essential component in bone health, promoting calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, which enable normal mineralization of bone.
Read the detailed description
Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease affecting approximately 1% of the population older than 50 years. There is a worldwide increase in disease prevalence due to the increasing age of human populations. The disease is characterized by tremor, stiffness of the limbs and trunk, impaired balance and coordination, and slowing of movements, leading to immobility and frequent falls. Patients also sometimes develop other symptoms, including difficulty swallowing, disturbed sleep, and emotional problems. Parkinson's disease results from the loss of dopaminergic neurons in the substantia nigra region of the brain. The cause and mechanism of continued neuron cell death in the substantia nigra is currently unknown.
Epidemiological studies suggest an association between Parkinson's disease and osteoporosis, vitamin D inadequacy and altered bone and mineral metabolism. Accumulating evidence indicates that patients with Parkinson's disease are at a higher risk for fractures compared to healthy subjects. This could be attributed to several contributing factors including increased rate of falls, vitamin D deficiency, reduced body mass index and reduced bone mineral density.
- Conditions
- Parkinson Disease
- Being tested
- Vitamin D3, Placebo
- Keywords
- Parkinson's Disease, Parkinson Disease, PD, Movement Disorder
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Vitamin D, Vit D, Vit D3
Vitamin D3
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplementation | Experimental | 1000 IU/day of Vitamin D3 Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct changes in bone formation and resorption will be investigated by measuring serum 25-hydroxyvitamin D [25(OH)D] level,serum parathyroid hormone (PTH) levels, serum osteocalcin, and serum n-telopeptides (N-Tx)
Measured: 12 months
Secondary outcomes (4)
Serum clacium will be measured to monitor for hypercalcemia.
Measured: 12 months
Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms
Measured: 12 months
Using the Parkinson's Quality of Life measure (PD QoL) to examine the effect of vitamin D supplementation on quality of life
Measured: 12 months
Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Sharon Plank, MD, Principal investigator, Conemaugh Health SystemPrema Rapuri, PhD, Principal investigator, Conemaugh Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907972
- Sponsor's protocol ID
- MMC 08-30
- Acronym
- PDVD3
- Status last verified
- Jul 2013
- First submitted
- 22 May 2009
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study
- ClinicalTrials.gov ID
- NCT00907972
- Acronym / sponsor ID
- PDVD3 / MMC 08-30
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Parkinson Disease, PD, Movement Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Memorial Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 May 2009 (estimated)
- 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.
Health care burdens from neurodegenerative diseases are expected to increase disproportionately. Increasing age also predisposes this same population to other chronic diseases including osteoporosis, a progressive systemic skeletal disease characterized by low bone mass, which leads to an increase susceptibility to fractures. In the United States, 44 million people are estimated to be at risk for osteoporosis and low bone mass emphasizing the enormity of this public health problem.
Parkinson's disease is a progressive neurodegenerative disorder affecting about 1 million people. Evidence indicates that Parkinson's disease patients are at a higher risk for low bone mineral density, which can contribute to increased fractures compared to healthy subjects. In fact, several risk factors of osteoporosis in patients with PD have been identified, including advanced stages of PD, low body mass index, inadequate sunlight exposure and decreased vitamin D levels. Some or all of these factors in conjunction with decreased immobilization that may occur with PD, put patients at increased risks for fractures. Few studies however have examined bone markers in PD patients. Even fewer studies have examined the impact of Vitamin D supplementation on bone metabolism and mineralization in PD patients.
Vitamin D is an essential component in bone health, promoting calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, which enable normal mineralization of bone.
Detailed description
Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease affecting approximately 1% of the population older than 50 years. There is a worldwide increase in disease prevalence due to the increasing age of human populations. The disease is characterized by tremor, stiffness of the limbs and trunk, impaired balance and coordination, and slowing of movements, leading to immobility and frequent falls. Patients also sometimes develop other symptoms, including difficulty swallowing, disturbed sleep, and emotional problems. Parkinson's disease results from the loss of dopaminergic neurons in the substantia nigra region of the brain. The cause and mechanism of continued neuron cell death in the substantia nigra is currently unknown.
Epidemiological studies suggest an association between Parkinson's disease and osteoporosis, vitamin D inadequacy and altered bone and mineral metabolism. Accumulating evidence indicates that patients with Parkinson's disease are at a higher risk for fractures compared to healthy subjects. This could be attributed to several contributing factors including increased rate of falls, vitamin D deficiency, reduced body mass index and reduced bone mineral density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplementation | Experimental | Dietary Supplement: Vitamin D31000 IU/day of Vitamin D3 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be >18 yrs of age
- Subject must have a diagnosis of Parkinson's disease (Hoehn and Yahr stages I-III), confirmed by the study physician designated to complete patient staging
- Subject must sign the informed consent documentation according to MMC's IRB guidelines
- Subject must be willing and able to complete all study requirements at the designated time intervals
- Subject must agree to be randomized
Key exclusion criteria (9 listed)
- Subjects < 18 years old
- Parkinson's disease patients with Hoehn and Yahr stages IV-V.
- Subjects not willing and able to complete all study requirements at the designated time intervals
- Subjects who do not agree to be randomized
- Subjects receiving treatment with bisphosphonates (more that 3 months), parathyroid hormones (PTH) or PTH derivatives, e.g. Teriparatide or Fluoride, in the last 6 months.
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 D3Also: Vitamin D, Vit D, Vit D3Vitamin D3 | Dietary supplement | Vitamin D3 supplementation |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Direct changes in bone formation and resorption will be investigated by measuring serum 25-hydroxyvitamin D [25(OH)D] level,serum parathyroid hormone (PTH) levels, serum osteocalcin, and serum n-telopeptides (N-Tx)
Time frame: 12 months
4 secondary outcomes
Serum clacium will be measured to monitor for hypercalcemia.
Time frame: 12 months
Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms
Time frame: 12 months
Using the Parkinson's Quality of Life measure (PD QoL) to examine the effect of vitamin D supplementation on quality of life
Time frame: 12 months
Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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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. This study is not recruiting at the moment.
Sharon Plank, MD principal investigator
Conemaugh Health System
Prema Rapuri, PhD principal investigator
Conemaugh Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Parkinson Disease, run by Memorial Medical Center at 1 site in United States.
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 9 inclusion and 9 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: finished, as of the sponsor's last update on 12 Jul 2013. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct changes in bone formation and resorption will be investigated by measuring serum 25-hydroxyvitamin D [25(OH)D] level,serum parathyroid hormone (PTH) levels, serum osteocalcin, and serum n-telopeptides (N-Tx) (time frame: 12 months). 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 12 Jul 2013.