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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Memorial Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Parkinson Disease, PD, Movement Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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*

Sites / Locations

  • Conemaugh Health System - John P Murtha Neuroscience and Pain Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 supplementation

Placebo

Arm Description

1000 IU/day of Vitamin D3

Placebo

Outcomes

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)

Secondary Outcome Measures

Serum clacium will be measured to monitor for hypercalcemia.
Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms
Using the Parkinson's Quality of Life measure (PD QoL) to examine the effect of vitamin D supplementation on quality of life
Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study

Full Information

First Posted
May 22, 2009
Last Updated
July 11, 2013
Sponsor
Memorial Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00907972
Brief Title
The Effects of Vitamin D and Bone Loss in Parkinson's Disease
Acronym
PDVD3
Official Title
Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Medical Center
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Parkinson Disease, PD, Movement Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 supplementation
Arm Type
Experimental
Arm Description
1000 IU/day of Vitamin D3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Vitamin D, Vit D, Vit D3
Intervention Description
Vitamin D3
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Serum clacium will be measured to monitor for hypercalcemia.
Time Frame
12 months
Title
Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms
Time Frame
12 months
Title
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
Title
Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Plank, MD
Organizational Affiliation
Conemaugh Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prema Rapuri, PhD
Organizational Affiliation
Conemaugh Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Conemaugh Health System - John P Murtha Neuroscience and Pain Institute
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States

12. IPD Sharing Statement

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

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