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The Effects of Vitamin D and Bone Loss in Parkinson's Disease (PDVD3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907972
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : July 12, 2013
United States Department of Defense
Information provided by (Responsible Party):
Memorial Medical Center

Brief 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 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: Vitamin D3 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vitamin D3 supplementation
1000 IU/day of Vitamin D3
Dietary Supplement: Vitamin D3
Vitamin D3
Other Names:
  • Vitamin D
  • Vit D
  • Vit D3

Placebo Comparator: Placebo
Other: Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Serum clacium will be measured to monitor for hypercalcemia. [ Time Frame: 12 months ]
  2. Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms [ Time Frame: 12 months ]
  3. 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 ]
  4. Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • 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*

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907972

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United States, Pennsylvania
Conemaugh Health System - John P Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, United States, 15904
Sponsors and Collaborators
Memorial Medical Center
United States Department of Defense
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Principal Investigator: Sharon Plank, MD Conemaugh Health System
Principal Investigator: Prema Rapuri, PhD Conemaugh Health System
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Responsible Party: Memorial Medical Center Identifier: NCT00907972    
Other Study ID Numbers: MMC 08-30
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013
Keywords provided by Memorial Medical Center:
Parkinson's Disease
Parkinson Disease
Movement Disorder
Additional relevant MeSH terms:
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Parkinson Disease
Vitamin D
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents