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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Memorial Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Department of Defense
Information provided by:
Memorial Medical Center
ClinicalTrials.gov Identifier:
NCT00907972
First received: May 22, 2009
Last updated: June 7, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Parkinson Disease
 Dietary Supplement: Vitamin D3
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum clacium will be measured to monitor for hypercalcemia. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
 Other: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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*
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907972

Contacts
Contact: Monica Updyke, RN,BSN, CCRC (814) 269-5201 mupdyke@conemaugh.org
Contact: Lisa Pasierb, PhD (814) 269-5248 lpasierb@conemaugh.org

Locations
United States, Pennsylvania
Conemaugh Health System - John P Murtha Neuroscience and Pain Institute Recruiting
Johnstown, Pennsylvania, United States, 15904
Contact: Monica Updyke, RN,BSN,CCRC     814-269-5201     mupdyke@conemaugh.org    
Contact: Lisa Pasierb, PhD     (814) 269-5201     lpasierb@conemaugh.org    
Principal Investigator: Sharon Plank, MD            
Principal Investigator: Prema Rapuri, PhD            
Sponsors and Collaborators
Memorial Medical Center
Department of Defense
Investigators
Principal Investigator: Sharon Plank, MD Conemaugh Health System
Principal Investigator: Prema Rapuri, PhD Conemaugh Health System
  More Information

No publications provided

Responsible Party: Sharon Plank, MD, Memorial Medical Center - JPM Neuroscience and Pain Institute
ClinicalTrials.gov Identifier: NCT00907972     History of Changes
Other Study ID Numbers: MMC 08-30
Study First Received: May 22, 2009
Last Updated: June 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Medical Center:
Parkinson's Disease
Parkinson Disease
PD
Movement Disorder

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013